Food and Drug Administration (FDA) Inspections and External Audits

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Policy Number:
UW-4083
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy describes the required actions to be taken when a member of a UW–Madison study team conducting Food and Drug Administration (FDA)-regulated human subjects research is notified of an inspection by the FDA or audit by another external agency (e.g., National Institute of Health [NIH], Office for Human Research Protections [OHRP], U.S. Department of Agriculture [USDA], etc.). 

Scope:

 Financial audits are out of the scope of this policy. 

Policy:

Successful handling and completion of FDA on-site inspections (or that of other federal agencies evaluating the conduct of FDA-regulated research) are vital to the university’s research mission. Often perceived as an arduous process and time-sensitive event, the FDA Regulated Research Oversight Program helps support and guide involved investigators and study teams prior to, during, and following such federal inspection. Notification and involvement of the program not only help individual investigators being audited, but they also: assure federal agencies that the university is appropriately engaged in FDA-regulated research oversight; enable individual inspection observations to be trended over time; and allow appropriate cross-campus process improvement opportunities to be identified and implemented.

  1. The principal investigator (PI) and/or other study team member(s) must notify the program immediately upon notification from the external agency of impending audit or inspection by sending an email correspondence to inspection-notification@lists.wisc.edu. The study team will be asked to provide known information (e.g., PI name, Institutional Review Board [IRB] Number, IND/IDE [investigational new drug/ investigational device exemption] Number(s), date(s) of the planned audit/inspection, type of and/or reason for the audit/inspection, etc.).
  2. The PI/study team must work with program staff and applicable UW–Madison institutional representatives throughout the audit/inspection and provide updates to the program throughout the inspection.
  3. The PI/study team must coordinate scheduling the exit interview or close-out meeting with the auditor/inspector and applicable program and institutional representatives by emailing inspection-notification@lists.wisc.edu. Member(s) of the program and institutional representatives should be present during the exit interview or close-out meeting to answer institutional policy and procedure-related questions.
  4. If the FDA or external agency is requesting written responses to inspection observations, the PI/study team must provide all written responses to the program and institutional representatives to review and approve prior to submission to the regulatory agency.
  5. The PI/study team must promptly provide program and institutional representatives with copies of any further communication(s) to and from the regulatory agency regarding the audit/inspection by emailing inspection-notification@lists.wisc.edu
External References:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Administrative Director FDA Regulated Research Oversight Program
Contact:
Administrative Director FDA Regulated Research Oversight Program -- Jacob Rome, rome2@wisc.edu, (608) 265-3890
Date Issued:
04-11-2018
Revised Dates:

11-15-2019

Retrieved:
12-06-2024 21:34:59