After the FDA Inspection

The FDA will usually hold an exit interview at the conclusion of the inspection.

• 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.
• Outcomes: Possible outcomes include No Action, Voluntary Action Indicated, or Official Action Indicated. If serious deficiencies have been found during the inspection, Inspectional Observations (FDA Form 483) will follow listing the deficiencies. If no deficiencies are found, or the inspector has comments that she or he believes are not serious enough to warrant an FDA Form 483, no form will be issued.
• Opportunity to Clarify: During the discussion, the Principal Investigator needs to ensure everything is clear and understood. The PI should ask for clarification, but demonstrate knowledge of the regulatory requirements, IRB requirements, and applicable SOPs. Observations, comments, and commitments should be noted in the inspection notes. Adopt a collaborative approach (identify root cause), but don't over-promise corrective actions, particularly if they are inconsistent with standard practice.
• Confirm Details of Written Response: The PI should state that their official response to any Inspectional Observations will be provided in writing. During the discussion, the PI should ask the FDA Inspector to clarify the specific date when the written response is due, as there is sometimes ambiguity about whether the PI has 15 business (preferred) or calendar days, and whether certain holidays are observed by FDA. Confirm where to send the response (address and recipients).

The following steps must be completed within the 15-day timeframe set by the FDA Inspector during the exit meeting:

1. Obtain a copy of the UCSF template Form 483 response letter from FDAConsults@ucsf.edu
2. Principal Investigator drafts the proposed response
   • Determine if a finding was an oversight/one-time occurrence; or systemic, where a change of procedure is indicated.
   • Delineate corrective actions: including justification of why the proposed response will remediate the issue and a realistic timeline for correction.
   • If the PI disagrees with an observation: respond factually, providing clear and verifiable evidence.
   • Address each particular observation or finding, point by point.
3. The Office of Ethics Compliance Regulatory Support, and the IRB QIU provide feedback on the draft 
4. Near-final draft is circulated to the Sponsor (if applicable) and UCSF Office of Legal Affairs (Legal requires at least 1 week to review the near-final draft, so plan accordingly)
5. PI is responsible for submitting the final response to the FDA (retain a copy in your study file)

• The PI will receive notification from the FDA as to whether the response to the Form 483 was adequate. If the FDA does not  accept the PI's initial response, immediately notify the appropriate contacts in the IRB QIU, Office of Ethics and Compliance Regulatory Support, and Legal Affairs.
• The FDA has recently adopted a practice of providing the PI with a copy of the Inspector's final field audit report, called an Establishment Inspection Report (EIR), within months of the inspection closing date.
• If a copy of the EIR is not provided, the PI or their designee may request a copy under the Freedom of Information Act (FOIA Request).  FDA typically will not respond to an EIR request until the matter is formally closed.