FDA 483 - Ponce Medical School Foundation, Inc. IRB - February 24, 2023

The FDA issued a Form 483 to Ponce Medical School Foundation, Inc. in Ponce, PR, following an inspection of its Institutional Review Board. The inspection revealed significant deficiencies in IRB record-keeping, including inadequate meeting minutes, improperly maintained member lists, and a lack of written procedures for reporting unanticipated problems and notifying the institution of research decisions. These issues indicate a failure to ensure proper oversight and documentation of human subject research.