Tuesday, February 24, 2009

Dos and Don't during and after FDA inspections

This is a collection of facts from different experts and not the whole thing, there might be other dos and don'ts other than these applicable as per particular situation.
  • Present business card
  • Be prepared
  • Be organized
  • Be calm
  • Be professional
  • Be confident
  • Have Scribe present at all times during the interview
  • Leave as soon as interview is over
  • Listen carefully and repeat the question or ask it to be repeated, if necessary
  • Answer completely, directly and honestly
  • Speak slowly and clearly
  • Speak only for your area of expertise
  • Know your procedures
  • Examine the credentials of the inspector, and establish the purpose of the inspection (e.g., routine, for cause, or survey).
  • Immediately inform corporate management and staff that an inspection is under way, and tell these individuals what the purpose of the inspection is.
  • Work out a rough schedule for the visit so that key personnel can be made available
  • Be able to verify everything you say
  • Prepare everyone in the firm who might come into contact with the inspector.
  • Train all such individuals with the procedures to be followed during the inspection
  • make sure all understand the role of the inspection coordinator.
  • Familiarize these individuals with a list of inspection do’s and don’ts
  • Inspection co-ordinator must stay all the time with the inspectors.
  • Inspection co-ordinator should have a runner to fetch information which is not in hand or to inform other about the stage of the inspection.
  • Inspection co-ordinator should think that he/she is the company as far as investigator is concerned
  • be positive in attitude and speak with authority and confidence
  • Interact with other company employees - those working in the plant as well as those in staff groups.
  • Effectively guide questions posed by the inspector to people with both the knowledge and the verbal skills to answer them.
  • smoothly challenge inappropriate questions immediately.
  • Focus on the positive aspects of a situation rather than getting defensive about negative aspects
  • Communicate inspection results on a continuing basis.Summarize the results more formally after the inspection is complete
  • Expect what you say to be documented in FDA field notebook
  • communicate clearly that there will be full cooperation within the law
  • Give Complete responses to valid questions, be open to the investigator’s point of view
  • Have a writtent policy about responsibilities
  • Representatives of the corporate quality, regulatory affairs, and legal departments are immediately informed that an inspection is taking place and are told what the purpose of that inspection is
  • Allow copying of records and access to a copier
  • Keep a second copy and attach to the inspection coordinator’s report
  • Allow FDA to take sample and retain a copy of sample and receipt
  • Follow up to see that all written comments (e.g., 483s) and verbal comments have been addressed and resolved


  • Do not make casual conversation
  • Do not assume the investigator is your “buddy”
  • Do not guess or make up an answer
  • Do not lie
  • Do not volunteer more information than necessary to completely answer the question
  • do not answer in way that looks to be rehearsed or artifical
  • Do not make faces or jokes about company's expenses
  • Make the auditor wait for the information
  • Override a liasion decision infront of auditors
  • Do not show auditors , your computers, but under FDA inspectors can see your comupter in a proper setting with proper personnel who are familiar with your systems present with them
  • Do not speculate. Don’t be afraid to find information and give it to the investigator later
  • Do not assume to know what the investigator means
  • Ask for clarification, examples or specifies
  • Do not conduct the inspection for the investigator
  • Never question the investigator’s authority
  • Never argue or raise your voice
  • Bring several people into conference room and have several conversations going on at one time
  • Provide documents with post-it notes, etc.
  • Do not agree or volunteer to change a procedure or practice without first discussing with Management
  • Respond to questions that are improper or outside your area of expertise or authority
  • Threaten to contact the investigator’s boss if conflict develops.
  • Allow Photographs
  • do not forget to make a decision which items to be given to inspectors, which to show and retain and which is to be exclusively used by co-ordinator
  • uncontrolled interchanges between personnel and the inspector


  1. Would you suggest entering the room carrying your specific functions SOPs to reference or provide to the investigator? Or is this what the ready room documents are for? Does it look strange walking in with a folder full of SOPs?

    1. No, do not bring all of your SOPs and other documentation into the room where FDA or other investigators are currently located. Only bring from your Ready Room specifically what is being requested or required on behalf of FDA and/or investigators. Yes, it’s strange walking in with a folder full of SOPs and also risky because you are providing compliance auditable records for review and the investigator could review these and have more questions or queries for you and lead the investigator down a different pathway. Only provide what is being requested or required and this is why we have the Ready Room/War Room/Staging Room to facilitate the documentation process.