FDA 483 - Wills Eye Hospital IRB - October 17, 2025

An FDA inspection of Wills Eye Hospital IRB in Philadelphia revealed significant deficiencies in its written procedures. The Institutional Review Board lacked established protocols for verifying material changes, reporting unanticipated problems, addressing noncompliance, and handling the suspension or termination of IRB approvals. These issues indicate a systemic failure to maintain adequate procedural controls for critical IRB functions.