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.
Dos

  • 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

Don’ts

  • 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