FDA Inspection Readiness: During an Inspection
In our previous blog, FDA Inspection Readiness: Preparing for an Inspection we reviewed how to prepare for a Food and Drug Administration (FDA) inspection. We will continue to outline FDA inspection readiness steps, including what to expect during the inspection.
During the Inspection
Once the inspector arrives at a site, the host should review the inspector’s credentials and will receive a FDA Form 482, “Notice of Inspection”. After the FDA Form 482 is presented, escort the inspector(s) to the inspection room. Always escort the inspector(s) throughout the site and never let the inspector(s) wander on their own.
When called to speak with the inspector(s), introduce yourself by stating your name, your position, and your role, confirm the study being inspected and describe your responsibilities in that study. Make sure your ID badge is visible; if you do not have an ID badge, you may also present a business card. The inspection host or another site manager will be with you during the interview, it is recommended that employees should not be alone with the inspector during an interview.
During the interview, make sure you clearly understand the question so you can answer the question concisely. You can ask for the inspector(s) to rephrase their question. If you do not know the answer, state that you will get back to the inspector(s) with the information. You should only answer questions that relate to your role in the study. For example, the study coordinator should not answer questions directed to the Principal Investigator (PI) and the PI should not defer questions to the study coordinator. Additionally, do not answer questions outside your area of responsibility, do not guess, and do not volunteer information. Throughout the entire process, respect the silence and the environment. Many times, people feel the need to fill the silence by talking more, however, this is a tactic that interviewers use in their favor so the interviewee will volunteer information. You may need to work extremely hard to remain silent after you have answered the posed question and await the next question.
Provide the inspector with requested documents in a timely fashion. If there is a problem obtaining a document, let the inspector(s) know when they can expect the document. Maintain a list or copy of the documents provided to the inspector(s). It is helpful to have a scribe available to record the questions asked, documents requested and who can ensure all documents have been provided to the inspector. This can also be done by the inspection host.
At the end of each day, the inspector(s) may or may not debrief with the site team to discuss any issues or observations and/or to make document requests for the next inspection day. The PI and site managers should respond at once to any observation and work to clarify or correct any potential errors or misunderstandings while the inspection is ongoing. Meeting with the inspector(s) for the daily debrief and addressing issues as they occur helps to minimize surprises if a Form FDA 483 is issued at the end of an inspection. (2020 Investigations Operations Manual, section 5.2.3)
The inspection is complete, now what? Check out our next blog, FDA Inspection Readiness: After the Inspection.
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