Presentation reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses
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Presentation reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
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• General Considerations
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• How to Find Problems
• Special Considerations
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September 24, 2014 presentation to the Outsourcing in Clinical Trials: Southern California Conference, sponsored by Arena Conferences, focusing on:
* Clarifying exactly what you are responsible for and what you made be held accountable for
* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
Crisis Management for FDA-Regulated Firms -- The Generic Drug Scandal as a H...Michael Swit
Audio conference on Crisis Management for FDA-regulated firms, using the Generic Drug Scandal of the late 1980's as a model. In particular, reviewed how a crisis can evolve, how to address, SEC disclosure duties, collateral consequences, and lessons learned.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
Presentation reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Regulatory & Quality Considerations in Virtual Drug DevelopmentMichael Swit
Presentation to Strategies for Success in Virtual Drug Development Conference on April 15, 2013, in San Diego, focusing on:
• General Considerations
• Why Quality & Regulatory Matter
• What Problems to Look For
• How to Find Problems
• Special Considerations
The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis LiabilityMichael Swit
September 24, 2014 presentation to the Outsourcing in Clinical Trials: Southern California Conference, sponsored by Arena Conferences, focusing on:
* Clarifying exactly what you are responsible for and what you made be held accountable for
* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
Crisis Management for FDA-Regulated Firms -- The Generic Drug Scandal as a H...Michael Swit
Audio conference on Crisis Management for FDA-regulated firms, using the Generic Drug Scandal of the late 1980's as a model. In particular, reviewed how a crisis can evolve, how to address, SEC disclosure duties, collateral consequences, and lessons learned.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
The Small Company Clinical Study SponsorRoles & Duties Vis-à-vis LiabilityMichael Swit
This document summarizes a presentation given by Michael Swit on roles and responsibilities of small company clinical trial sponsors and how to minimize liability when outsourcing clinical trial activities. Key points discussed include clarifying what sponsors are responsible for versus outsourcing partners, ensuring compliance of outsourcing partners, maintaining oversight of critical trial activities in-house, and explaining to funders that quality must be prioritized over cost.
FDA Warning Letters: Key Legal and Tactical Issues in Dealing with FDA's "Sh...Michael Swit
April 30, 2014 webinar sponsored by Duane Morris, with a focus on:
• Why FDA Issues Warning Letters – and How the
Agency Expects Management to Act When You Get
One
• How to Respond to A Warning Letter
• Inspection Responses That Failed to Hold Off FDA
From Issuing a Warning Letter (quick review)
• FDA Powers Beyond the Warning Letter – What the
Agency Can Do to You if It Does Not Like Your Reply
• The Evidentiary Status of a Warning Letter in Other
Litigation – J&J v. State of Arkansas
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
This document summarizes a presentation on responding to FDA inspections and warning letters. It discusses Commissioner Hamburg's 2009 speech that revived FDA's compliance culture and enforcement efforts. It outlines FDA's expectations for timely responses to Form 483 observations and warning letters. It provides tips for how companies can prepare for and handle inspections, including designating personnel roles and training employees. It also offers guidance on writing effective responses to Form 483s and warning letters that address each violation, present corrective actions, and minimize future regulatory risks.
FDA’s New Strategy on Enforcement: The Growing Perils of Inadequate ComplianceMichael Swit
September 9, 2009 webinar sponsored by The Weinberg Group, with a focus on FDA's renewed commitment to enforcement announced by FDA Commissioner Hamburg on August 6, 2009, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
This document summarizes a presentation about increased FDA enforcement of compliance. It discusses trends in FDA inspections, warning letters, seizures, and injunctions prior to 2009. It outlines a 2009 speech by FDA Commissioner Hamburg that revived the agency's compliance culture and established new enforcement mandates, including imposing deadlines for inspection responses, prioritizing follow-up on warnings, and taking rapid action when public health is at risk. The presentation advises preparing for enforcement by establishing a culture of compliance, building robust quality systems, and responding promptly and completely if targeted. It notes the serious consequences of non-compliance for companies and individuals.
FDA Regulation of Advertising and Promotion -- Handling Promotional Complianc...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
This document summarizes a training session on handling promotional compliance at the company level. It discusses that companies need a system with procedures, training, records, audits and validation. It also recommends having a team that includes medical, R&D, regulatory, labeling, marketing, legal, and compliance review promotional materials. Additionally, it outlines key measures companies can take to protect themselves, including implementing an effective compliance program with written policies, a compliance officer, training programs, auditing, and responding promptly to any issues.
FDA Enforcement -- the Perils of Inadequate ComplianceMichael Swit
Presentation on December 3, 2009 to Southern California Biomedical Council Regulatory Workshop, Irvine, CA, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance
Culture – The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA Inspections: Handling the Consequences. Dealing with the aftermath of an...Michael Swit
Presentation at annual MAGI conference, focusing on FDA inspections, covering:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
The document provides guidance on preparing for a pre-approval inspection (PAI) by the FDA. It discusses understanding what to expect from an FDA inspection team, developing an inspection management plan, and preparing the facility and documentation. Key steps include conducting internal audits and mock inspections, training personnel, reviewing documents that will be examined, and designating an inspection team to manage document requests and escort inspectors. The goal is to demonstrate compliance and control over any issues, rather than hiding problems from inspectors.
The Application Integrity Policy (AIP): A Little HistoryMichael Swit
Presentation to March 13, 2018 webinar sponsored by the Food & Drug Law Institute (FDLI) on Data Integrity, in which I reviewed the origins of the AIP and its role in FDA's enforcement armamentarium.
Ensuring FDA Regulatory Success for Biomedical CompaniesMichael Swit
February 27, 2008 presentation to the Israeli Life Sciences Fellows of the Merage Foundation on product development issues, including:
* Overall Planning
* Working With FDA
* Clinical Trial Execution
* CMC and Design History Issues
* Safety Issues
* Labeling
* Ingredients –Active And Inactive; Component for Medical Devices
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
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How to Respond if Targeted
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Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
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Excited to share insights from my recent presentation on genocide! 💡 In light of ongoing debates, it's crucial to delve into the nuances of this grave crime.
Business law for the students of undergraduate level. The presentation contains the summary of all the chapters under the syllabus of State University, Contract Act, Sale of Goods Act, Negotiable Instrument Act, Partnership Act, Limited Liability Act, Consumer Protection Act.
Corporate Governance : Scope and Legal Frameworkdevaki57
CORPORATE GOVERNANCE
MEANING
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2. www.duanemorris.com
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• This presentation, and the materials included
herewith, are provided for general educational
purposes and should not be construed as legal
advice.
2
3. www.duanemorris.com
What I Will Cover
• FDA’s Expectations on Replying to Inspections &
Warning Letters – the August 2009 Hamburg Speech
• How to Handle The Actual Inspection
• How to Respond to 483s & Warning Letters
• Lessons from Actual Responses
3
5. www.duanemorris.com
The Answer Is Simple – Comply!
• But, how? –
• Please Teach Vigorous Risk Avoidance
Comprehensively & Corporately
– Thus, to ensure you comply, you must have:
P = Procedures
T = Training
V = Validation
R = Records
A = Audits
C = Communications – open channels
C = Compliance Culture from the Top
5
11. www.duanemorris.com
Hamburg: Why We Need
Effective FDA Enforcement
• Conceded FDA enforcement efforts have been
deficient
• Five key benefits of effective enforcement:
– Protect public health by promptly intercepting unsafe or
fraudulent products – prevents additional harm
– Deter others who might violate law
– Informs public of potential harm
– Creates level playing field for industry
– Instill public confidence in FDA
11
12. www.duanemorris.com
Hamburg: Four Essential Elements for
Effective FDA Enforcement
• Vigilance – both FDA and Industry
– FDA – Regular inspections and follow-ups
– Companies
Must work quickly and thoroughly to correct problems
Must understand
if you cross the line, “you will be caught”
If you fail to act, FDA will
• Strategic enforcement –
– Greater focus on significant risks and violations
– More meaningful penalties to “send a strong message to
discourage future offenses”
12
13. www.duanemorris.com
Four Essential Elements for
Effective Enforcement …
• Quick action – FDA must respond rapidly,
especially to:
– Egregious violations
– Violations that threaten the public health
• Visible efforts – FDA must show all stakeholders it
is on the job
– Will publicize enforcement actions widely – including
rationales for action
– Goal:
Increase confidence in FDA
Deter non-compliance
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Six New FDA Enforcement Mandates …
• Impose clear post-inspection deadlines
– Generally –15 business days to respond to 483
– After that, agency can issue warning letter or take other
enforcement action
• Speed the warning letter process – by limiting
review by FDA Office of Chief Counsel to warning
letters that present significant legal issues
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Six New FDA Enforcement Mandates …
• Work more closely with FDA’s regulatory partners
– Example: in some cases, such as food safety, state, local, and
international officials can act more quickly than FDA
– When public health is at risk, the agency will coordinate with
its regulatory partners to take rapid action
• Prioritize follow-up on all warning letters and other
enforcement actions
– FDA will work quickly to assess the corrective action taken by
industry after a warning letter, a major product recall, or other
enforcement action
– Via new inspection or other form of investigation
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Six New Enforcement Mandates …
• FDA will be prepared to take immediate action to
respond to public health risks
– Actions may occur before a formal warning letter is issued – at
any time
– Days of multiple responses to inspections – over
• Develop and implement a formal warning letter
“close-out” process
– If FDA determines a firm fully corrected violations in a
warning letter, agency will issue an official “close-out” notice
and post on FDA Web site
– Seen as an “important motivator” for corrective action
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Enhanced Enforcement In Action –
Timely 483 Responses Policy
• Aug. 11 Federal Register notice – Post-inspection
483 responses timing policy published – 15 business
days
• Timely Responses
– FDA will conduct “detailed review” in deciding any
enforcement action
– If FDA issues a warning letter, letter will address sufficiency
of response
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Enhanced Enforcement In Action –
Timely 483 Responses Policy …
• Late responses
– Response will not be considered by FDA in deciding to take
enforcement action such as a warning letter
– If warning letter issues after a late 483 response, FDA will
consider the 483 response in assessing firm’s later reply to
warning letter
• Purpose of Warning Letter:
– “ensure … seriousness and scope of the violations are
understood by top management … and that the
appropriate resources are allocated to fully correct the
violations and prevent their recurrence”
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How to Prepare for an Inspection
• Know the training and tactics of FDA Investigators
– Investigations Operations Manual (IOM)
http://www.fda.gov/ICECI/Inspections/IOM/default.htm
See how FDA approaches inspections
– Compliance Program Guidance Manuals
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProg
ramManual/ucm2005382.htm
– Other Guidance Documents
• Review other Companies’ 483s and Warning Letters
– know what the current “hot buttons” are
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Preparing for an Inspection
• Have a written corporate policy for FDA inspections
• Establish attitude of the company – must come from the
top
• Conduct independent external audits and internal
audits – find the problems before FDA does
– FDA policy – written audits done under a regular audit
procedure are normally not subject to inspection [see
Compliance Policy Guide #130.300); exceptions:
“Directed" or "for-cause" inspection and investigations of a sponsor or monitor of a clinical
investigation;
In litigation
Inspection warrant where access to records is authorized by statute; and
Judicial search warrant.
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm07
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Train Personnel for Inspections
• Every employee must know his/her job function
and regulatory obligations
• Designate an inspection coordinator
• Document employee credentials, training and
knowledge
– QA/QC, GCP documentation
– Study, manufacturing and other protocols
– FDA program and inspection guidance documents
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Corporate Inspection Policy & Procedures
• Address GCP, GMP, GLP and other types of
inspections/inquiries
• Designate Who will interact with FDA Investigator
– Inspection Coordinator and Inspection Group
– Clinical Director Study Coordinator/Principal Investigator
– Production Employees
– Receptionist/Secretary
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Inspections of Records
• What records will be made available – know what you
must disclose under Section 704
• Have specific policies on:
– photographs
– tape recorders
– copying records (shipping, financial and business records)
• Questioning of personnel
– no duty to answer verbal questions, but the reality is you should
– don’t speculate; if don’t know; say you will find out
• Sampling –
– if FDA samples, you sample
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Personnel Interacting With Inspector(s)
• Receptionist/Secretary -- confirm FDA is at correct
name and institution (e.g., Par v. Parmed; Par v.
Barr); record inspector’s badge number
• Never leave investigator unattended
• Receptionist should have list of inspection
coordinator and alternate persons:
– Clinical Director / Study Coordinator / Principal Investigator
– Production V.P. / Quality Control Manager
– Executive V.P. / President
– Legal Counsel
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Duties of Inspection Coordinator
• Examine Credentials and 482 Forms
• Ask What Type of Inspection
• Write down all pertinent information
– contact core group
internal
external – you should have key experts identified in advance
e.g., “micro” expert
FDA attorney
– work out inspection agenda
– inform investigator of corporate policies – e.g. photographs
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General Tactics During Inspection
• Designate a Conference Room
• Don’t Allow Access to Areas Beyond Scope of
Inspection under § 704
– You get the items if needed
• Never Mislead the Investigator
• Don’t Panic (i.e., missing documents, questions)
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Defensive Strategies During/After
Inspection to Avoid Enforcement
• Draw the investigator into a conversation when a
problem is identified:
– more details (so that I may investigate);
– how/why is what we are doing (apparently) inadequate (so I
may explain to management)
• Daily Debriefs
– internally after each day of inspection
– try to get FDA inspector to do a daily debrief
what is planned for next day
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FDA Investigative Techniques for
Gathering Evidence During Inspections
• Questioning employees at home at night or on the
weekend
• Permitted under FDCA Sec. 704
• Can go through trash, obtain grand jury subpoenas
and search warrants for telephone and business
records
• Collaboration with FBI and FDA’s OCI
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Home Interviews …
• Prepare employees to contact company legal
counsel before speaking with an investigator (this
assures no waiver or corporate privilege or
disclosure of confidential information)
• Company SOP should reflect desire to cooperate
with FDA to the extent that company understands
the purpose of the investigation and will not waive
or jeopardize its or its employees legal rights
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Inspection Exit Interview
• 483 Observations
• Ask For:
– Explanation and Details
– Examples
• Write Down Exactly What Investigator Says
– some firms are videotaping (OK by FDA per IOM)
• If observation has been corrected, ask that to be
noted on the 483
• If observation is wrong, politely engage in
dialogue. If you can show, inspector may delete
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Disagreements with 483 Observations
• Make notes of your requested comments and
include them in your 483 response
• Never “argue” with inspector
• Never make verbal promises, only written
responses – be careful with correction timelines
• Affidavits
– Never sign them and don’t even listen to a reading
– If they push, ask them to send to your attorney for review
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The Response – Assessing Allegations
• Assess each allegation/observation
– Focus on specifics
– Focus on system-wide implications
– Focus on global implications
– Consider affected products
– Consider root-cause analysis
• Focus on the regulatory requirement(s) associated
with each allegation/observation
• Develop corrective action plan to achieve
immediate, short-term, and long-term correction
and to prevent recurrence
– Know when to seek outside assistance
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The Written Response
• Provide specific evidence to minimize public health
risk
– number/scope of product’s distribution
– ability to do stock withdrawal or recall
– technical assessment
• If inspection follows product recall,
– Note company was “on the ball” and caught the problem, as it
was supposed to; foreclosing greater risk
– If did not catch, say what changes are being made to catch
sentinel events/data in the future
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Written Response to the 483
• Address each observation separately
• Never agree that an observation is valid:
– instead, state changes you intend to make
• Disagreements:
Present your argument – remember – Science wins!!
Be responsive, not argumentative
• Attach copies of changed documents
• Time lines –
– be specific, but be sure
– deliver what you promised when you promised it
Send in follow-ups when due on timelines
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Keys to The Written Response
• Show the likelihood of recurrence of the
problem/violation is low
• Show the company is doing all it can reasonably to
remedy the situation: specific steps, timetable,
monitoring
• Problems attributable to a specific cause have/will
be fixed with permanent remedies
• Show that senior management understands
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FDA Expectation on Your Response
• Wants to Hear Your D.R.U.M. – expects your
response to have these qualities:
– Direct – i.e., address the items directly raised in the 483 or
warning letter
– Related – go beyond those to potentially related problems
– Universal – expand to review those issues company-wide
– Monitoring and Management –
show that you will stay on top of the issues
show that senior management is involved
Source: “Compliance and Enforcement.” Presentation by David K. Elder, Director, FDA Office of
Enforcement, at the Orange County Regulatory Affairs (OCRA)/FDA Joint Educational
Conference. June 15, 2005. Irvine, California.
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483/EIR: Inspection Results
• NAI – “No action indicated” -- no objectionable
conditions or practices were found during the inspection
(or the objectionable conditions found do not justify
further regulatory action)
• VAI - “Voluntary action indicated” -- objectionable
conditions or practices were found, but the District is
not prepared to take or recommend any administrative
or regulatory action
• OAI – “Official action indicated” -- regulatory and/or
administrative actions will be recommended
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FDA Enforcement Discretion
• Prior History of Company’s Compliance
– 483’s, warning letters, recalls, etc. -- and company’s
response(s)
• Health risks
• Likelihood of recurrence
• Discretion in action –
– K-V vs. FDA – Makena® pharmacy compounding; just
filed in federal court in D.C. on July 5
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Failure to Implement Corrections
• 7) Failure to adequately establish procedures for corrective and preventive action;
as required by 21 CFR 820.100(a). For example, your firm's CAPA procedures, QOP-
85-04, Corrective and Preventive Action do not require written documentation when
proposing a Corrective Action Request, therefore limiting the ability to determine
recurrence of nonconforming product or quality problems. Your firm has not defined
what constitutes a sufficiently serious or recurring nonconformity'' in either your
Corrective and Preventive Action procedures or your Supplier Evaluation and
Monitoring procedure, (QOP 74-01) to define the criteria to initiate a Corrective Action
Request. Additionally, your Control of Non-Conforming Product procedures (QOP-83-
01) allow your form to close out non-conforming product reports if a disposition
decision is made to "scrap" or accept product "as is" without further evaluation to
determine if a corrective or preventive action is appropriate. Your responses, dated
March 7, 2012 and May 29, 2012 were inadequate. Your promised Corrective
actions have not yet been implemented.
• American OptiSurgical --
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309410.htm
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Inadequate Corrections
• Failure to develop, maintain, and implement written Medical Device
Reporting (MDR) procedures, as required by 21 CFR Part 803.17.
• For example: Your firm’s procedure does not include the requirements for submission
of MDRs to FDA. Your firm’s procedure, (b)(4) as written, does not establish internal
systems that provide for timely and effective identification, communication, and
evaluation of events that may be subject to MDR requirements, a standardized review
process or procedure for determining when an event meets the criteria for reporting,
timely transmission of complete medical device reports, and documentation and
recordkeeping requirements, as required by 21 CFR Part 803.17.
• We reviewed your firm’s response dated June 1, 2011, and conclude that it
is not adequate. Although you provided an English translation of your
firm’s procedure, (b)(4) it does not meet the requirements of 21 CFR Part
803.17 as stated above.
• Aesculap AG
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011
/ucm273502.htm43
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Repeat Violations
• The first postmarketing adverse drug experience (ADE) reporting
compliance inspection of Acorda Therapeutics was conducted in 2006.
Observations from the 2006 inspection included late submission of 15-day
Alert reports, failure to develop written procedures, and failure to submit
follow-up reports. A second postmarketing ADE reporting compliance
inspection of Acorda Therapeutics was conducted in 2009. Observations
from the 2009 inspection included late submission of Field Alert Reports
and the repeat findings of late submission of 15-day Alert reports and
failure to develop written procedures. Additionally, during the 2009
inspection, the FDA Investigator noted that your firm did not complete
corrective actions until 2007, even though your response to FDA, dated
January 19, 2006, stated that all corrections had been made.
• Acorda Therapeutics
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012
/ucm303979.htm
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Not Including Revised/New Procedure
• Failure to establish and maintain procedures for receiving, reviewing and
evaluating complaints to determine whether the complaint represents an
event which is required to be reported to FDA under 21 CFR Part 803,
Medical Device Reporting, as required by 21 C.F.R. § 820.198(a)(3). From
December 2011 - January 2012, your firm received at least 11 complaints of
artifacts associated with the use of the Bella blanket during mammography
procedures. Review of these complaints revealed that you determined an
adverse event was not required, however, your firm did not obtain the
information necessary to make this determination. For example, you did not
assess whether a mammogram needed to be repeated or if the artifacts had the
potential for misdiagnosis for each complaint. Your response did not include
a revised complaint procedure.
• Beekley Corporation
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012
/ucm309890.htm
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Failure to Address Allegation
• 3. Failure to document the results of finished
acceptance activities as required by 21 CFR
820.80(e)(3). We acknowledge that you have
implemented a specification that your Bella blankets to
now include a “point” pattern, however you are not
recording the results of your inspections on your weekly
“Production Report Release approval “ forms. Your
response does not address this violation.
• Beekley Corporation
• http://www.fda.gov/ICECI/EnforcementActions/Warning
Letters/2012/ucm309890.htm
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Not Addressing Cause of an Observation
• 5. Design validation did not include adequate risk analysis, as required by
21 CFR 820.30(g). For example, the risk analysis for the Adjustable Laser
Probe was incomplete, in that the Failure Mode and Effect Analysis (FMEA)
was not assessed for new risk determinations or for the revision of risk priority
numbers following a report of a device malfunction on June 21, 2010.
We have reviewed your response and have concluded that it is not adequate.
Your response to the observation was to cease distribution of the Adjustable
Laser Probe and to voluntarily recall the product. This response does not
address the corrective action necessary to address the cause of the
observation to prevent its recurrence. The observation merely used this
device as an example of a deviation. You must assure that design control
procedures are adequately established for all of its applicable devices.
• Peregrine Surgical --
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010
/ucm238045.htm
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Inspection Observations Clash with Reply
• 1. Failure of management with executive responsibility to establish its
policy and objectives for, and commitment to, quality. Failure of
management with executive responsibility to ensure that the quality
policy is understood, implemented, and maintained at all levels of the
organization, as required by 21 C.F.R 820.20 (a).
We have reviewed your responses and have concluded that they are inadequate.
Your response of April 15 states that quality procedures have been improved
over the past 11 months and that meetings are held frequently to ensure full
Quality System regulation compliance. However, evidence obtained during
this inspection does not support this assertion. You do not appear to be
following your Quality Manual, for example failing to maintain complete
design controls records, and to document verification and validation
activities.
• Allez Spine
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008
/ucm1048186.htm48
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Failure to Do Root Cause Analysis
• d. Your firm has failed to thoroughly investigate several
customer complaints. For example, you received complaint
#(b)(4) on March 1, 2010, citing dark particulate matter in a vial of
Heparin. You investigated and determined that the particle was
most likely due to a vendor issue; however, you did not perform an
assessment of the vial supplier.
• In your response, you state that you have not identified any other
defects of this nature. Your response is inadequate since you
have not addressed the potential root cause of a vial defect as
identified in your investigation.
• APP Pharmaceuticals
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012
/ucm293068.htm49
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Please Teach Vigorous Risk Avoidance
Comprehensively & Corporately
• Thus, to ensure you comply, you must have:
– P = Procedures
– T = Training
– V = Validation
– R = Records
– A = Audits
– C = Communications – open channels
– C = Compliance Culture from the Top
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Questions?
• Call, e-mail or fax:
Michael A. Swit, Esq.
Special Counsel, FDA Practice
Duane Morris LLP
San Diego, California
direct: 619-744-2215
fax: 619-923-6248
maswit@duanemorris.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
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About Your Speaker
Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm,
Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by
highly-regulated pharmaceutical and medical device companies. Before joining Duane Morris in
March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a
preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes
product development, compliance and enforcement, recalls and crisis management, submissions
and related traditional FDA regulatory activities, labeling and advertising, and clinical research
efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and
therapeutic biotech products. Mr. Swit has been addressing vital FDA legal and regulatory issues
since 1984, both in private practice with McKenna & Cuneo and Heller Ehrman, and as vice
president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty
drug firm. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of
regulatory newsletters and other specialty information products for FDA-regulated firms. He has
taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.
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