Overview
During an FDA Inspection, the Principal Investigator (PI) and study team members should follow these recommended best practices.
Meeting the FDA Inspector on Day 1
- After greeting the Inspector, confirm their credentials and provide introductions.
- Attendees: The escort, Principal Investigator, representatives from the Institutional Review Board Quality Improvement Unit (IRB/QIU), Office of Ethics and Compliance Regulatory Support, and other individuals as appropriate should be notified of the time and place and expect to attend.
- Receive FDA Form 482, Notice of Inspection, from the Inspector. Generally the most responsible individual who is present receives the Form 482.
- Tour only the areas the Inspector will need to access (office, restroom, cafeteria), unless the Inspector specifically requests to visit research space.
- Accompany the FDA Inspector at all times other than when they are in the designated conference room reviewing documents. FDA inspectors should not be allowed to enter patient care areas or research staff workspace areas unescorted at any point during the inspection.
Providing Documents and Materials Requested by the FDA Inspector
- Documents: Provide requested records. The PI or designee will make two (2) copies of each record requested by FDA; one for FDA, and one for retention on site following the inspection.
- Photographs: If the FDA inspector insists on taking photographs, take duplicates at the same time.
- Samples: If the FDA inspector requests a reasonable quantity of samples, fill the request but pull identical samples to retain. Ask the FDA to issue a receipt for the samples (FDA Form 484). Depending on the nature of samples requested, advise the FDA that an invoice will be presented.
If the FDA Inspector makes a document request that may contain information falling outside the scope of the inspection, such as requesting all emails sent on a certain date or containing a specific subject line, the PI must inform the inspector that UCSF requires advance notice and the opportunity to (i) ensure responsiveness to inspectional scope, and (ii) redact information over which FDA has no inspectional authority, including protected medical information (e.g., the California Confidentiality of Medical Information Act (CMIA)).
Responding to the FDA Inspector's Questions
- Contact FDAConsults@ucsf.edu external site (opens in a new window) for tips on responding to questions during the inspection (e.g., Listen to the question; answer the question that was asked. Defer to others if you don't know; when possible use documents already provided for support of answers. Stop when the question is fully answered.)
- Ensure that each question is answered by the person(s) most knowledgeable on the issue.
- Arrange any interviews requested by the FDA Inspector, and escort the FDA Inspector if they request to go to the pharmacy, etc. Document the name and title of all persons interviewed by the FDA, and the date (and time if possible) of the interview.
- Try to resolve as many issues as possible, as soon as possible.
- Arrange for follow-up as required for any unanswered questions or outstanding document reports.
Take Notes During the Inspection
- Take notes concerning the progress of the inspection. A form may be used to assist in this task, with spaces for the FDA Inspector’s name (if a team inspection), documents requested, date and time of request, date and time delivered.
- Document any line of questioning pursued by the PI and the FDA Inspector, including issues that could not be resolved and steps taken during the inspection to resolve the issue.
Debrief Daily
- The PI or designee should request an end of day discussion during each day of the inspection with the FDA Inspector to review any preliminary findings.
- The PI or designee will document any questions whose answer could not be provided, along with appropriate follow-up to obtain the requested information.
- Ask the Inspector about the plan for the next day and the anticipated length of visit.