FDA 483 - Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc. IRB - January 23, 2026

Auxilio Mutuo Hosp IRB #1 in San Juan, PR, was inspected and found to have significant deficiencies in its Institutional Review Board (IRB) operations. The inspection revealed a lack of proper documentation for meeting votes, absence of critical written procedures for reporting, and issues with IRB composition and member rosters. These findings indicate a moderate level of non-compliance with regulatory requirements for human subject protection.