This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.

1. FDA Compliance:
FDA Inspections
A Practical GuideA Practical Guide
byby
Compliance Insight, Inc.Compliance Insight, Inc.
513-860-3512513-860-3512
www.Compliance-Insight.comwww.Compliance-Insight.com

2. Preparing for the Audit
You should always be prepared for anYou should always be prepared for an
audit!audit!
If you only prepare things just prior to an audit,If you only prepare things just prior to an audit,
it is very apparentit is very apparent
fresh paint over poorly prepared materialfresh paint over poorly prepared material
all documents just signed or signed very recentlyall documents just signed or signed very recently
very apparent that hurried work was performedvery apparent that hurried work was performed
Last minute general cleaning and organizing isLast minute general cleaning and organizing is
expectedexpected

3. Preparing for the audit
Most inspections are not announcedMost inspections are not announced
General GMP inspections are performed approximatelyGeneral GMP inspections are performed approximately
every two yearsevery two years
Pre-Approval Inspections (PAIs) are performedPre-Approval Inspections (PAIs) are performed
following submission of filings with the FDAfollowing submission of filings with the FDA
ANDAANDA
NDANDA
For Cause Inspections performed following an issueFor Cause Inspections performed following an issue
recallrecall
complaintscomplaints

4. Preparing for the Audit
Some general things toSome general things to
keep in mindkeep in mind
A place for everythingA place for everything
and everything in itsand everything in its
placeplace
First impressions areFirst impressions are
very importantvery important
Have documents readilyHave documents readily
availableavailable

5. Preparing for the Audit
Make sure any prior observations fromMake sure any prior observations from
auditors are completedauditors are completed
Were they completed on time?Were they completed on time?
Were they effective in resolving the problem?Were they effective in resolving the problem?
If there were any issues, make sure they wereIf there were any issues, make sure they were
explained.explained.
If things are not done, make sure you have aIf things are not done, make sure you have a
good excuse!!!good excuse!!!
What have you done in the interim???What have you done in the interim???

6. Preparing for the Audit
Conduct mock inspectionsConduct mock inspections
internal personnelinternal personnel
corporate personnelcorporate personnel
consultantsconsultants
Evaluate your quality systemEvaluate your quality system
prepare for a systemic inspectionprepare for a systemic inspection

7. Preparing for the Audit
PAIPAI
Prepare a “war room”Prepare a “war room”
Pull all documents relevant to the filingPull all documents relevant to the filing
batch recordsbatch records
stabilitystability
validationvalidation
raw material receiptsraw material receipts
testing datatesting data
cleaning validationcleaning validation
raw material supplier auditsraw material supplier audits
PM recordsPM records
calibration recordscalibration records
change control fileschange control files
Filing (final)Filing (final)
water/HVAC datawater/HVAC data
investigationsinvestigations
use/cleaning logsuse/cleaning logs

8. During the Audit
Receive FDA Form 482Receive FDA Form 482
Notify all partiesNotify all parties
Retrieve information as requestedRetrieve information as requested
PAI - Don’t drop off the FDA in your “warPAI - Don’t drop off the FDA in your “war
room” and let them look through everything.room” and let them look through everything.
Gather data quicklyGather data quickly
evaluate data prior to giving it to the inspectorevaluate data prior to giving it to the inspector
Train people how to communicate with theTrain people how to communicate with the
FDAFDA

9. During the Audit
Be prepared to walk through the facilityBe prepared to walk through the facility
Have someone there to take notesHave someone there to take notes
Keep copies of whatever copies you give toKeep copies of whatever copies you give to
the inspectorsthe inspectors
Be aware that the inspector is looking atBe aware that the inspector is looking at
previous commitments and has read the EIRprevious commitments and has read the EIR
FDA should approach issues systemicallyFDA should approach issues systemically

10. During the Audit
General items evaluatedGeneral items evaluated
Returned goodsReturned goods
reason why and dispositionreason why and disposition
CompliantsCompliants
InvestigationsInvestigations
Batch RecordsBatch Records
Validation ProtocolsValidation Protocols

11. During the Audit
Ask as the day progresses or at the end ofAsk as the day progresses or at the end of
the day about observations or questionsthe day about observations or questions
This give you a chance to make corrections orThis give you a chance to make corrections or
clarify misunderstandingsclarify misunderstandings
Keep on top of thingsKeep on top of things
Don’t become overconfidentDon’t become overconfident
Many small observations can lead to “the strawMany small observations can lead to “the straw
that broke the camel’s back”that broke the camel’s back”

12. Following the Audit
Make sure you return ALL informationMake sure you return ALL information
pulled for the inspectionpulled for the inspection
Don’t dispose of any documents until youDon’t dispose of any documents until you
have accounted for everythinghave accounted for everything
You may want to have a master list ofYou may want to have a master list of
documents pulled to reference when youdocuments pulled to reference when you
start returning thingsstart returning things

13. Following the Audit
Corrective Action Plans (CAP)Corrective Action Plans (CAP)
Direct response to investigatorDirect response to investigator
findingsfindings
Initiated by and based on the 483Initiated by and based on the 483
or Warning Letteror Warning Letter
Limited in scope to the systemsLimited in scope to the systems
that FDA reviewedthat FDA reviewed
Corrective Actions to beCorrective Actions to be
performed as committed in timeperformed as committed in time
frame committedframe committed
Response to FDA is public recordResponse to FDA is public record

14. Following the Audit
GMP Enhancement MasterGMP Enhancement Master
Plans (GEM)Plans (GEM)
Preparation may be unrelated toPreparation may be unrelated to
the FDA inspectionthe FDA inspection
Initiated and controlled internallyInitiated and controlled internally
An overall comprehensiveAn overall comprehensive
assessment of the firms Qualityassessment of the firms Quality
SystemsSystems
Corrective Actions can be plannedCorrective Actions can be planned
and modified as necessaryand modified as necessary
May be held as Confidential andMay be held as Confidential and
Proprietary InformationProprietary Information

15. The Close Out Meeting
Who should attendWho should attend
Regulatory AffairsRegulatory Affairs
Quality AssuranceQuality Assurance
ProductionProduction
Upper ManagementUpper Management
Any other pertinentAny other pertinent
individualsindividuals

16. The Close Out Meeting
Decide in advance on responseDecide in advance on response
strategystrategy
Go through each itemGo through each item
If errors are present, commentIf errors are present, comment
Corrections made during theCorrections made during the
inspectioninspection
Corrected and verifiedCorrected and verified
Corrected and not verifiedCorrected and not verified
Correction promised by ___Correction promised by ___
No commentNo comment
Commit to a written responseCommit to a written response
within a given time periodwithin a given time period

17. Re-establish Credibility
Evaluate the current state ofEvaluate the current state of
compliance in light of the FDAcompliance in light of the FDA
inspectioninspection
Collectively analyze each citationCollectively analyze each citation
Review prior FD-483s to determineReview prior FD-483s to determine
if all commitments were indeedif all commitments were indeed
metmet
Note any repeat observationsNote any repeat observations
Identify the Root CauseIdentify the Root Cause
Relate each issue to the appropriateRelate each issue to the appropriate
Compliance and Quality SystemsCompliance and Quality Systems

18. Re-establish Credibility
Develop a correctiveDevelop a corrective
action plan (CAP) aroundaction plan (CAP) around
the entire scopethe entire scope
Secure required resourcesSecure required resources
– financial and personnel– financial and personnel
Assign responsibilitiesAssign responsibilities
and accountabilityand accountability
Do not makeDo not make
commitments that can notcommitments that can not
be honored.be honored.
Notify FDA of any setNotify FDA of any set
backs or missed timelinesbacks or missed timelines

19. Prepare to be Reinspected
Assure that the firm metAssure that the firm met
their commitmentstheir commitments
Assure that the resolutionAssure that the resolution
encompassed the rootencompassed the root
cause and that it wascause and that it was
comprehensivecomprehensive
Monitor warnings to otherMonitor warnings to other
companies, regulatorycompanies, regulatory
actions, and GMP trendsactions, and GMP trends

20. Root Cause of the 483Root Cause of the 483
With the FDA’s new systemic approach
the FDA wants a systemic review of all your
systems
don’t just “fix” the issue, determine the root cause,
evaluate the solution and implement corrective
actions
evaluate across the board
are there other systems with the same or similar problems

21. The End?
Any Questions???Any Questions???
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