FDA WARNING_LETTER - Hospital Municipal de San Juan - November 21, 2007

On August 15, 2008, the FDA issued a Warning Letter to Luis A. Medina, M.D., IRB Chairman at Hospital Municipal de San Juan, following an inspection from November 15-21, 2007. The inspection aimed to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in FDA-regulated clinical studies.

The FDA concluded that the IRB failed to adhere to statutory requirements and regulations. Key violations included: 1. **Inadequate Documentation of IRB Activities (21 CFR 56.115(a)(2))**: Meeting minutes lacked sufficient detail to show actions taken, with one protocol re-approval (August 19, 2006) not documented in minutes. Nine instances of approval decisions made on meeting dates were not documented in minutes, and three expedited approvals lacked documentation or mention in subsequent meeting minutes, contrary to the IRB's own procedures (21 CFR 56.110(c)). 2. **Improper Meeting Quorum (21 CFR 56.108(c))**: The IRB approved research at the April 20, 2006, meeting without the required presence of at least one nonscientific member. 3. **Failure to Notify Investigators (21 CFR 56.109(e))**: The IRB failed to provide