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