1. DOs and DON’Ts
of
Handling FDA Inspection
Dr.Arun Purohit

2. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Do be professional and confident
 Be well dressed and neat.
 Be presentable (shave, hairs, nails,etc.)
 Be decent and polite
 Be courteous at all times
 Correct all errors/miscommunications as soon
as possible
Dr.Arun Purohit 2

3. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Feel confident of your company’s ability to meet and
exceed not only the audit requirements, but the
regulatory requirements. Your confidence of being
compliant should be radiant throughout the course of
the audit. If the company or the company personnel
are not confident of their ability or meet regulatory
compliance, then this too, becomes evident during
the course of an audit and a good auditor can spot
this.
Dr.Arun Purohit 3

4. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Treat audits with the professional pro-active
‘do-diligence’ exuberance, and enthusiastic
demeanor. Do not shy away or hide from the
process. This demeanor can radiant
throughout the course of the audit.
Dr.Arun Purohit 4

5. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Escort the inspector at all times
 Act in a courteous and professional manner
 Require that all requests from the inspector
go through your inspection team
Dr.Arun Purohit 5

6. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Provide documents in an accurate and timely
manner
 Handle document requests with care
 Limit the inspector’s access to the records,
facilities and materials that are subject to
inspection
 Attempt to clarify or correct
misunderstandings or assumptions
Dr.Arun Purohit 6

7. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Review the requested record before sending
into the room for the investigator. Check that
the record is the one asked for.
 Send only the record and not the entire file.
 Check for any missing signatures or entries
or missing pages
Dr.Arun Purohit 7

8. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Check that no undue paper is appended to the
record.
 Ask for clarification when necessary
 Avoid undue traffic in and out of the room.
Remove records which have been reviewed
from the room
 Show one record at one time
Dr.Arun Purohit 8

9. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Check that no undue paper is appended to
the record.
 Ask for clarification when necessary
 Avoid undue traffic in and out of the room.
Remove records which have been reviewed
from the room
 Show one record at one time
Dr.Arun Purohit 9

10. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Have all relevant documents/raw data readily
accessible – preferably assembled in one
central location.
 Be very familiar with content and location of
all reports/data, SOPs etc. Long delays in
responding to questions are undesirable.
Dr.Arun Purohit 10

11. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Make scrupulous notes of
comments/concerns/ deficiencies pointed out
by the inspector.
 Have all records organized and available.
Give the inspected only those records
specifically requested
 Clarify or attempt to resolve issues as they
are made known.
Dr.Arun Purohit 11

12. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Do balance cooperation with wariness
 Be cooperative with the investigator to the
extent possible, but politely disagree when
appropriate
 Be brief in what you say-no stories
 Appear confident-think before you say
 Always tell the truth
Dr.Arun Purohit 12

13. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Try to Develop a “Relationship”. You know
the product better than FDA and that needs to
be conveyed.
 Challenge yourself with the “Difficult”
questions. Have Brief, Coherent, Logical
explanations available.
Dr.Arun Purohit 13

14. HANDLING FDA INSPECTION
DOs and DON’Ts
Dos
When a question is asked
 Take a deep breath
 Listen carefully to the Inspector’s questions
 Pause and formulate a proper response
 Answer only after the question is fully stated. Be
confident of your answer.
Dr.Arun Purohit 14

15. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
When a question is asked (cont…)
 Request clarification to questions not understood
 Answer only what was asked
 Provide a clear, concise, and honest answer
 Only answer questions within your job responsibilities
otherwise direct the question to “Subject Matter
Experts”
Dr.Arun Purohit 15

16. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
When a question is asked (cont…)
 Speak slowly and clearly-one word at a time
 Keep unnecessary conversation to a minimum
 Answer briefly to the question only
 Answer only if you are sure.
 Communicate clearly and effectively
 Focus on positives
Dr.Arun Purohit 16

17. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Assume a friendly, cooperative attitude - but do not
overdo it. Avoid creating an adversary relationship.
Project an attitude of confidence and professionalism.
 If management is seen as "uncooperative," the
investigator may well become suspicious and more
zealous.
 Review pertinent plant policies e.g., policies
pertaining to cameras, recorders, wearing apparel,
and safety equipment during the opening interview
Dr.Arun Purohit 17

18. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Focus on the positive aspects of a situation
rather than getting defensive about negative
aspects.
 Avoid uncontrolled interchanges between
personnel and the inspector.
 Make a complete write-up of the inspection.
 Pass the question to your senior if you do not
have the answer
Dr.Arun Purohit 18

19. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 If the inspector is ‘digging’ or asking the same
basic question, provide more information as answers
may not be complete.
 Talk about what is and not what might be or
should be.
 If a problem has surfaced, point out where
GMP and quality system controls have worked
and how improvements have been made.
Dr.Arun Purohit 19

20. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Acknowledge and document areas that you
know need development.
 Implement a thorough communication
strategy.
 Provide information on relevant policies and
procedures to staff involved in the inspection
in advance.
Dr.Arun Purohit 20

21. HANDLING FDA INSPECTION
DOs and DON’Ts
DOs
 Do provide timely and carefully prepared
written responses to 483s, and to any letters
issued by FDA regarding violations identified
as a result of the inspection. Often, it is
appropriate to include a plan for corrective
action. FDA wants to see that management is
taking these issues seriously.
Dr.Arun Purohit 21

22. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Do not try to “Snow” the inspector, wrong
information is worse than no information.
 Don’t try to control the conversation
 Don’t try to lead the inspection
 Don’t try to change the agenda
Dr.Arun Purohit 22

23. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Avoid language using typically, normally,
generally, and usually, as possible
 Do not make Major changes to policies and
procedures in the weeks leading up to the
inspection.
Dr.Arun Purohit 23

24. HANDLING FDA INSPECTION
DOs and DON’Ts
Don'ts
 Do not write and implement Standard
Operating Procedure that are overly complex
and above the required standards. You will be
inspected to your SOPs as well as the
regulatory requirements. Failing to meet your
SOPs will result in inspection finding even if
you are meeting the regulatory requirements.
Where possible use ‘guidance’ instead of rigid
SOPs
Dr.Arun Purohit 24

25. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Don’t try any distraction techniques
 Speak unless asked for.
 Guess, lie, deny the obvious, or make
misleading statements
 Engage in unconstructive argument. (Avoid
win/lose or legalistic confrontations.)
Dr.Arun Purohit 25

26. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Don’ts Attempt to answer “What if?” questions
or hypothetical questions
 Don't become argumentative or, worse,
hostile or make threatening remarks.
 Engage in arguments with peers in the
presence of inspectors
Dr.Arun Purohit 26

27. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Don’ts Allow FDA inspectors to go through
your files on their own. Ask them what they
want and provide it for them.
 Refuse appropriate requests from inspectors,
but try to narrow the scope of the request
when possible
Dr.Arun Purohit 27

28. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Do not try to hinder the progress of the Auditor by
time consuming idle conversations, lengthy
presentations or non-relevant alternate agendas.
 Do not challenge the auditor’s understanding of the
requirements and regulations. If challenges are
warranted, then those challenges must be made in
writing during the audit report’s resolution responses.
Dr.Arun Purohit 28

29. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Ask questions to the auditor
 Show off your knowledge.
 Say that something is impossible or couldn’t
happen. (This is a red flag that challenges
the inspector to find a way it could happen.)
 Don’t waste inspector’s time
Dr.Arun Purohit 29

30. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Be nervous
 Lie to the Inspector – it all ends in tears
 Get aggressive or be ‘clever’
 Fidget, shift around, touch your face etc.
 Chat in places the auditor may be i.e. toilets, corridors
etc.
 Do not sign affidavits
 Do not allow pictures
Dr.Arun Purohit 30

31. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Argue or extensively debate with the Inspector
 Argue with others when the Inspector is present
 Answer “off-the-record” questions
 Guess or provide approximate answers
 Interfere with the Escort/Inspection Team
Dr.Arun Purohit 31

32. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Correct other people in front of the Inspector
 Do not initial/sign any error
 Interrupt someone else’s answer
 Interrupt the Inspector’s comments and
explanations
 Provide your opinions
 Answer for someone else
Dr.Arun Purohit 32

33. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Use the Inspector as your consultant
 Challenge the auditor’s judgment
 Defend your answer by giving reference of
guideline or book.
 Contradict your colleague.
 Joke with the investigator
Dr.Arun Purohit 33

34. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Never allow unescorted “roaming”
 Volunteer information
 Get uptight. Fear is inappropriate, although genuine
concern may be expressed
 Murmur or whisper in presence of auditor.
 Do not speculate why the investigator is conducting
the inspection
Dr.Arun Purohit 34

35. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Pass slips / notes to each other.
 Hurt the ego of the investigator.
 Attempt to answer "what if" questions and
other hypothetical questions.
 Comment on the quality of the inspection
Dr.Arun Purohit 35

36. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Don’t have food in the lab
 Have clutter in your work area
 Quote what the SOP says, unless you’re
200% certain you know what you’re talking
about
 Be intimidated or defensive
 Don’t leave documents out on your desk.
Dr.Arun Purohit 36

37. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Leave inspectors alone while they are in your
plant
 Tell inspectors that records are unavailable.
You can say that you cannot locate the record
 Tell inspectors they are being unreasonable (even
when they are)
 Ask questions such as, “Where does it say we have to
do that?” Their response will likely be “Where does it
say that you don’t?”
Dr.Arun Purohit 37

38. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Do not provide excuses or shift blame (either
on previous employees, staff members, etc)
 Do not answer questions which lie outside
the authority of the Inspector (sales data,
personnel information relating to salaries,
performance reviews, etc)
Dr.Arun Purohit 38

39. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Do not try to hide, misplace, or make documents
unavailable to the Auditor(s). If a document does not exist,
honestly inform the Auditor that the document does not
exist or that the document is not available. Do not state
that a non-existent document is not available for review, as
the Auditor may request to see the document at a later
date. Do not state that the document is currently in process
of being drafted, as the Auditor may want to see the
preliminary writings. If the Auditor senses false statements
or finds no evidence of such statements, then this
impression of a ‘cover-up’ may set the tone for the rest of
the audit. Be honest, and forthcoming with the auditor(s).
Dr.Arun Purohit 39

40. HANDLING FDA INSPECTION
DOs and DON’Ts
DON’Ts
 Try not to argue with the Auditor as arguing
with an Auditor is like wrestling a pig in the
mud, after a while the pig starts to enjoy it. If
you would like to dispute an issue, then do so
on the resolution section of the audit
reports. Challenge the audit issue when and
where appropriate
Dr.Arun Purohit 40

41. HANDLING FDA INSPECTION
DOs and DON’Ts
Don'ts
When reviewing Records
 Point out errors
 Correct errors during the review
 Comment or “apologize” for the quality of the data
 Comment on plans to improve recordkeeping
practices, unless criticized by the Investigator
 Make constant references to planned SOP revisions,
unless criticized by the Investigator
 Provide a detailed explanation/ translation, unless
specifically requested
Dr.Arun Purohit 41

42. HANDLING FDA INSPECTION
DOs and DON’Ts
Don'ts
The language muddle
 Never speak behind the auditor in a language not
known to him
 If an operator is not able to understand the auditor’s
language, you should let him know first that you will
seek his response in the local language and then
translate for him
 Watch your body language too – be polite, patient,
attentive, respectful
 Auditor is a human being, and he is helping you
Dr.Arun Purohit 42

43. HANDLING FDA INSPECTION
DOs and DON’Ts
Confrontation
 Avoid confrontation
 You can not win
 So win him over to your side
Take the bull by the horns?
Dr.Arun Purohit 43

44. HANDLING FDA INSPECTION
DOs and DON’Ts
Dr.Arun Purohit 44

45. HANDLING FDA INSPECTION
DOs and DON’Ts
Choose your responses correctly
“Not us, another dept has done it ………”
 Remember you are not speaking to your boss
 You are speaking to an auditor
 Do not play games here
 Will show lack of inter-dept co-ordination
 Not an acceptable answer
Dr.Arun Purohit 45

46. HANDLING FDA INSPECTION
DOs and DON’Ts
Choose your responses correctly
“To be really honest with you ………..”
OR
“To tell you the truth ………”
 Means previously you were not so honest and true
 Raises suspicion in the auditor’s mind
 He may ask for replay !!
 Do not break the trust you built in so far
 Not an acceptable answer
Dr.Arun Purohit 46

47. HANDLING FDA INSPECTION
DOs and DON’Ts
Be wary of the “Long silence technique”
 Auditor asks you a question
 You answer
 Auditor listens
 Auditor maintains a long silence (purposely)
 You become anxious to break the silence
 You add more to the answers (mostly unwanted!)
 Auditor got enough to grill you!
 Don’t be over anxious to break the silence, answer
only to the point, not a word more
Dr.Arun Purohit 47

48. HANDLING FDA INSPECTION
DOs and DON’Ts
Unofficial is also official
 Never speak any so called unofficial thing
with the auditor
 There is nothing unofficial for an auditor when
he is at your site, everything he sees and
hears is official
Dr.Arun Purohit 48

49. Conclusion
 Be prepared to MANAGE the inspection
– Establish roles and responsibilities before
the inspection
– Have the necessary resources to
accommodate the number of inspectors
Dr.Arun Purohit 49

50. HANDLING FDA INSPECTION
DOs and DON’Ts
Dr.Arun Purohit 50