FDA Audit - The Do and Don't List

What your organization should do and should not do during a FDA audit or inspection. For more information go go http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/

1. Do’s and Don’ts During An FDA Inspection Copyrighted 2013 Compliance Insight, Inc.

2. When dealing with the FDA investigator, we should demonstrate knowledge of and confidence in our quality system . Not arrogant nor defiant… The DO’s During an Inspection Copyrighted 2013 Compliance Insight, Inc.

3. Never give false data, always tell the truth Is it OK to say “I don’t know”? The investigator may ask the same question to different people at different times The DON’Ts During an Inspection Copyrighted 2013 Compliance Insight, Inc.

4. The DON’Ts During an Inspection There are some “tricks” used to pull information from you during the audit Be aware of what you are saying and doing The “dome of silence” The tendency of people to try to fill a void with more information Talk, offer more info The “Hmmm… factor” Ask a question, write it down, shake your head or get a concerned look People take this as a “problem” and then offer more info to fill the gap Copyrighted 2013 Compliance Insight, Inc.

5. If the investigator asks you for some information, do not: make them ask for it again wait to see if they forget about the request The DON’Ts During an Inspection Copyrighted 2013 Compliance Insight, Inc.

6. It is not productive to argue with the investigator when responding to a question or observation Don’t challenge the investigator. There is no need for that. It only motivates curiosity and questions. The DON’Ts During an Inspection Copyrighted 2013 Compliance Insight, Inc.

7. Do not stand around making faces and looking worried. This makes people feel nervous and may alert the investigator that something may be wrong. Act confident and proud , not defensive . If a fellow employee is being questioned, do not try to help them by answering the questions yourself or by giving contradictory information. The DON’Ts During an Inspection Copyrighted 2013 Compliance Insight, Inc.

8. Do not interrupt the investigator or other employees when they are speaking Do not talk loud or speak with the others when the investigator is trying to concentrate, read or review documentation. It is not your job to fill an uncomfortable silence with additional explanation. The DON’Ts During an Inspection Copyrighted 2013 Compliance Insight, Inc.

9. The DON’Ts During an Inspection Loose lips sink ships! Don’t talk – even off site!!! Copyrighted 2013 Compliance Insight, Inc.

10. Things To Remember During An FDA Inspection Copyrighted 2013 Compliance Insight, Inc.

11. If it isn’t documented, it doesn’t exist Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

12. Investigator may “read” your body language Be aware of your body language Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

13. During the inspection, observe and learn to “read” the Investigator’s body language. Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

14. Verbal ~7% Paralinguistic ~38% Non-Verbal ~55% Communication Copyrighted 2013 Compliance Insight, Inc.

15. Intimate zone 0-1½ ft. Personal zone 1½-4 ft. Social zone 4-12 ft. Interview Orientation Copyrighted 2013 Compliance Insight, Inc.

16. Establish the “normal” behavior patterns So that you are aware of behavioral changes Interview Techniques Copyrighted 2013 Compliance Insight, Inc.

17. Upright Open & Relaxed Lean forward on occasion Aligned with Investigator Casual Posture Change Truthful Posture Copyrighted 2013 Compliance Insight, Inc.

18. Retreating Slouching Frozen Not aligned Barrier Posture Consistent posture changes Head & Body Slump Deceptive Posture Copyrighted 2013 Compliance Insight, Inc.

19. Composed Concerned/Realistic Cooperative Direct/Spontaneous Open/Helpful Sincere Confident Persistent/Consistent Truthful Behaviors Copyrighted 2013 Compliance Insight, Inc.

20. Overly Anxious Unconcerned/Unrealistic Uncooperative/Defensive Guarded/Evasive/Hesitant Rationalizing/Unhelpful Insincere Defeated Apologetic/Accepting Quiet Deceptive Behaviors Copyrighted 2013 Compliance Insight, Inc.

21. Breaking a Gaze Right = edit or fabricate Left = access memory I wonder if he’ll believe this? Yes, that is how it was done About 85% accurate but use only as a tool to determine if further questions need to be asked. Copyrighted 2013 Compliance Insight, Inc.

22. Stick to the facts not opinions. Do not use phrases such as: I think … I’m not sure but … In my opinion, it should … What you are saying is not true… Honestly… Usually… Typically… As I recall… Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

23. Listen to questions carefully Answer only what is asked. Do not volunteer information Clarify what you don’t understand before answering the question When a question is too broad, ask for specifics Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

24. If you don’t know the answer, say so. It is all right to say that you need to look into the situation further before answering. Do not guess if you’re not sure of the answer. Look it up in the procedure and or consult you peers, or another SME. If you are not a SME for a question asked, do not answer the question and explain to FDA this fact and get the right person. Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

25. If you think that the investigator has misunderstood something say so immediately explain why in a professional manner Things to Remember During an Audit Copyrighted 2013 Compliance Insight, Inc.

26. Phrases to Refrain From! That’s the way we’ve always done it Off the record… I probably shouldn’t say this but… Who, me? … Uh, no It’s probably a mistake. Copyrighted 2013 Compliance Insight, Inc.

27. If we would do it that way we would never get anything done We don’t have enough time or resources to follow that procedure I do it a different way because the procedure is not good If you think that’s bad you should see this... We fixed that problem by firing the person That’s not my fault, that was the previous supervisor … That’s not my problem, that’s Quality Assurance’s problem Write it on the FDA-483, it’s the only way we can correct it. Phrases to Refrain From! Copyrighted 2013 Compliance Insight, Inc.

28. Documents and Records The investigator is permitted to review : Documents and records pertaining to the control, manufacturing or quality assurance activities within the facility, as required by applicable federal regulations. These include (but are not limited to): Procedures Batch Records Regulatory Filings Quality Control Procedures Validation records Calibration/PM records Investigations Other records such as training records, job descriptions, procedures, promotional labeling etc., as defined in relevant parts of the FDA regulation unless otherwise specified. Documents that can not be reviewed by FDA: Reports of audits performed by internal auditors , customers , external auditors or consultants Records and documents pertaining to the financial matters of the company (sales data, pricing information, etc.) Research data/protocols (true “research” data is exempt from review, product development data can be reviewed by FDA) Personnel records other than training Management review meeting minutes Copyrighted 2013 Compliance Insight, Inc.

29. What happens if an investigator finds something wrong? Answer: Discuss concern/finding with investigator so you fully understand what the investigator understands. There should be no misconceptions. Ask questions. At the end of each day, we request an oral list of all observations. This gives us an opportunity to address issues before the close of the inspection and allows us to prepare responses to potential 483 observations. At the conclusion of the inspection, the investigator presents significant findings at the closing meeting on a FDA 483, List of Observations. If the findings are minor, the investigator may opt to do nothing except verbally advise the Regulatory representative and management of the concerns. Frequently Asked Questions Copyrighted 2013 Compliance Insight, Inc.

30. What happens if an investigator find something wrong? Answer (continued): Your firm will respond in writing to the Form 483 with a corrective action plan. We have to act quickly but effectively. Corrective Action Plan should address specific observations, systemic correction and time frame for implementing corrective actions . Frequently Asked Questions Copyrighted 2013 Compliance Insight, Inc.

31. Compliance Insight, Inc. 513-860-3512 For a Free Consultation www.Compliance-Insight.com Copyrighted 2013 Compliance Insight, Inc.