How To Survive FDA Inspection (003)

Listen carefully:

Respond directly to the question and only to the question. Ensure you understand the question; ask investigator for clarification or repeat/rephrase the question if needed:

(“Do I understand correctly: You would like to know…”).

Respond truthfully, factually, and accurately:

But: Only to what you are competent and what you were asked for. Don’t provide opinionsand don’t guess

Only answer questions within your scope of knowledge; defer if needed, but provide a followed-up response ASAP (“I don’t know, I’ll have to find out” may be the best answer – need to balance this with demonstrating staff’s competence)

Respond specifically to question asked: Provide complete responses but don’t volunteer information not requested or needed for a complete response (no need to show that you know everything!!!)

Respond with current practices (not past or future)

Stop talking after answering question: silence is fine

Avoid terms such as “typically,” “usually,” “generally,” I assume,” “I think,” “I believe,” etc.

Do not play games: Do not try to confuse the inspector by responding to something that has not been asked or by providing irrelevant information.

Do not guess: If you do not know or if you are not sure ask for more time to review details or other people to answer.

Document Review

• Provide documentation, ( only stamped) and only requested documentation! Remove Post-Its, hand notes and extra pages.)
• Allow investigator to review document; assist or point out information only if prompted by auditor/investigator
• Don’t point out errors or correct during the audit/inspection
• Don’t criticize data,
• do not contradict colleagues in front of the inspector.
• Remain friendly, cooperative, and professional; be calm and confident
• Be careful how you use humor
• Don’t be hostile, argumentative, or defensive
• Don’t verbally commit to anything
• Don’t seek the Investigator’s recommendation or advice
• Collaborate!

Words never to be used

• Usually
• Generally
• Sometimes
• Occasionally
• Normally
• Mostly
• Mainly
• Maybe
• To be honest…
• To be perfectly honest..
• If I can speak frankly
• I think
• I suppose
• I guess
• Be as positive as possible in all situations
• Assume that the inspector does not know:
  – your company
  – your product
  – You
• Realize the inspector may not always be correct
• Ask the inspector exactly which regulations are the source of his observations
• Inspectors are trained to read your body language

Inspectors are used to be „important“ persons.

• They don’t like to wait.
• People and documents quickly available.
• In time at start, – wrap up, -final meeting
• Be ready after the facility tour, after lunch…
• telephone on “silence” or “vibrator” in your pocket (the inspector is more important than any other call!!! Or go out of the inspection room to call; we have to show that we are concentrated on the inspection Do not “play” with your phone in presence of the inspectors.
• Introduce yourself (name, function, responsibility in our organization, business card) before starting a presentation.
• Silence in the inspection room, don’t speak with your colleagues or go out of the room.
• Close the door of the inspection room silently.
• Don’t speak during the tour with colleagues in the back of the inspectors in an other language that the inspection language. If needed tell to the inspectors what you are asking to your colleagues.
  (FDA inspectors may understand German incl. Swiss German!!!)
• During the facility tour show that your outfit is always in accordance to the hygiene principles ( feet or body against the wall!!!, touch any surface or equipment if not needed…)
• No need to show that you are tired when sitting in the inspection room!
• During lunch, break, before or after inspection time don’t speak about the company, our processes, people…
  choose topics like the Alps, Museum, Switzerland etc.