Preparing for your next FDA Inspection D3.pptx

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Robert Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
May 2014
How to Prepare for Your
Next FDA Inspection
http://bit.ly/FDA30min
Don’t act like the Keystone
Kops. Click on this link if you
want to know what to do
during the first 30 minutes of
an FDA inspector’s arrival.

of 29
rob@13485cert.com
May 2014
FDA Approach to Inspections
• District office develops schedule based upon
number of available inspectors
• Risk-based prioritization
• For cause inspections are top priority
• Class III manufacturers that have not been
inspected are second priority
• Any inspections postponed until the next
fiscal year move up in priority

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rob@13485cert.com
May 2014
Risk Classification
Class 1 – Low Risks Do Not Require
Pre-Market Notification [i.e. - 510(k)]
Class 2 – Moderate Risks Require 510(k)
& there are “Special Controls”
Class 3 – High Risks & Unknown Risks
Require Pre-Market Approval (PMA)

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rob@13485cert.com
May 2014
Purpose of FDA Inspections
• Monitoring of Class II & III Device Manufacturers
• Follow-up on Recalls and Adverse Events
• Monitoring of International Manufacturers
• Pre-approval Inspections for PMA Devices

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rob@13485cert.com
May 2014
QSIT Approach
108-page QSIT
Inspection Guide
http://bit.ly/QSITManual

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rob@13485cert.com
May 2014
QSIT Subsystems
• 4 Majors:
– Management Controls
– Design Controls
– Production & Process Controls
• Sterilization
– CAPA
• MDRs
• Corrections & Removals (i.e. – Recalls)
• 3 Minors:
– Facilities & Equipment Controls
– Material Controls
– Document/Record/Change Controls

of 29
rob@13485cert.com
May 2014
Types of Inspections
• Level 1 – Abbreviated QSIT (CAPA +1 Major)
• Level 2 – Comprehensive QSIT (All 4 Majors)
• Level 3 – Compliance Follow-up
• Special – For Cause

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rob@13485cert.com
May 2014
The FDA Always Looks at CAPA
CAPA’s are the heart of a Quality Management System
(QMS) and show inspectors where to look
CAPA’s
Risk Analysis
MAUDE
Clinicals
Effectiveness 
Service
Mngt. Review
Internal Audits
VOC Surveys
NCMR’s
Complaints
Validation

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rob@13485cert.com
May 2014
Management Review
• The FDA is not supposed look at this, but an
inspector may ask to see it anyway.
• What the FDA can request:
– Your procedure
– Evidence of Management Rep responsibility
– Date of the most recent reviews
– Agenda for the review
– Proof of attendance
– CAPAs resulting from Management Review

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rob@13485cert.com
May 2014
Internal Audits
– Your procedure
– Evidence of auditor training
– Your internal audit schedule
– CAPAs resulting from audits

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rob@13485cert.com
May 2014
Supplier Audits
– Your procedure
– Your Approved Supplier List (ASL)
– Your supplier audit schedule
– SCARs resulting from audits

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rob@13485cert.com
May 2014
How frequently will FDA Visit?
• FDA is required by statute to inspect U.S. Class II
or III medical device establishments once every
two years.
• In 2008, Class II manufacturers were inspected
once every 5 years, and U.S. Class III
manufacturers were inspected once every 3
years.
• In 2010, the FDA increased the number of
inspections by 25% (2,550 in 2009 & 3,174 in
2010)

of 29
rob@13485cert.com
May 2014
How Much Lead-time?
• US Inspections – the Friday before (or less)
– You can ask to post-pone, but it may not help you
– Ask for their name and if they will be coming
alone
– If more than one inspector is coming, ask if
someone is training
• International Inspections – 6-8 weeks in
advance

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rob@13485cert.com
May 2014
How the FDA Prepares
• Website Information
• Medical Device Reporting (Form 3500/3500A)
• Corrections & Removals (i.e. – Recalls)
• Registration & Listing
• 510(k) Submissions
• Previous Inspection Reports

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rob@13485cert.com
May 2014
Current Problem Areas
• Design Controls
• Investigation of Complaints
• Reporting of Adverse Events
• Purchasing Controls
• Part 11 Compliance
Be prepared for lot traceability audits.
DHF → DMR → DHR…
http://bit.ly/Part803Change
http://bit.ly/21_cfr_803_gapanalysis

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rob@13485cert.com
May 2014
Who should NOT speak to FDA?

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rob@13485cert.com
May 2014
Who should speak to the FDA?
• They never get nervous
• They always win a stare down
• They are ethical
• They listen carefully
• They say little

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rob@13485cert.com
May 2014
“Back Room” Preparations
• Don’t let the room get too crowded
• Make the this a “toll stop” for everyone entering
and exiting the inspection room
• Get a local printer & copier for the room
• Put a “drill sergeant” in charge
• Keep the creative R&D and Product Manager in
the “Back Room”—great ideas, but too much talk
• Give management transparency to the inspection
progress
• Keep the crew happy

of 29
rob@13485cert.com
May 2014
Inspection Room & Back Room
Back Room
Inspection Room
Scribe
SME
Management
Rep
FDA
“Drill
Sergeant”
Printer /
Copier
Food
Fridge
SME
On-Deck
Runner
Phones & Computers are
critical for communication
between rooms, the rest
of company and other
locations/suppliers
Speaker Phone
Projector
Projectors help the “Drill
Sergeant” communicate to
the rest of the back room
without the team looking
over their shoulder at a
laptop screen
R&D
Product Mngr.

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rob@13485cert.com
May 2014
FDA Document Requests
• Keep a log of document requests
– Which inspector requested it?
– When did the inspector request it?
– Who is the runner?
– When was it delivered to inspector?
• Never give the inspector an original
– Make 2 copies, mark each “Uncontrolled Copy”,
and date it
• Maintain a copy pile

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rob@13485cert.com
May 2014
483 Wording
• This document lists observations made by the
FDA representatives during the inspection of
your facility. They are inspectional observations
and do not represent a final Agency
determination regarding your compliance. If you
have an objection regarding an observation, or
have implemented, or plan to implement,
corrective actions in response to an observation,
you may discuss the objection or action with FDA
representatives during the inspection or submit
this information to FDA.

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rob@13485cert.com
May 2014
483 Wording (continued)
• The observations noted in this form FDA 483
are not an exhaustive listing of objectionable
conditions. Under the law, your firm is
responsible for conducting internal self audits
to identify and correct any and all violations
of the quality system requirements.

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rob@13485cert.com
May 2014
Most Common 483s in FY2013
http://bit.ly/Form483-FY2013
http://bit.ly/Download-Pareto483s

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rob@13485cert.com
May 2014
Inspection Outcomes
• No Action Indicated (NAI)
– No 483s
• Voluntary Action Indicated (VAI)
– 483 but no further action by FDA
• Official Action Indicated (OAI)
– 483 and further action by FDA
– Warning Letter; and/or
– Automatic Detention / Import Alert for Foreign
Manufacturers

of 29
rob@13485cert.com
May 2014
Avoiding Warning Letters
• You must respond to a 483 within 15 business
days
• Your corrective action plan must address each
observation
– Don’t forget corrections
– CAPA Training? – We’ve got that too.
• Do not give an inspector the impression that
your are obstructing the inspection or hiding
information
Documented in a 2009 notice by the FDA: http://bit.ly/15Dayresponse

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rob@13485cert.com
May 2014
Avoiding Automatic Detention
If you are a foreign firm, and you receive a
second warning letter with repeat findings, the
FDA will place your firm on “Automatic
Detention/Import Alert”.
You can’t ship product to USA for 12-18 months.
No second chances.

of 29
rob@13485cert.com
May 2014
What’s the real root cause?
• Ineffective training with regard to 21 CFR 820
– And 21 CFR 803
– And 21 CFR 806
• Webinar Title: “21 CFR 820 Compliance”
– 90-minute recording & 52-slide deck = $129
– 20-question exam & training certificate = $49
– FDA Leaving without an observation = Priceless
http://bit.ly/QA-RA-Webinars

of 29
rob@13485cert.com
May 2014
Q & A
rob@13485cert.com

of 29
rob@13485cert.com
May 2014
Do you need a
Mock FDA Inspection?
Rob Packard
rob@13485cert.com
+1.802.258.1881
rob13485

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