St Mary's Hospital and Medical Center, Inc. – FDA Warning Letter, Jun 15, 2012

The FDA conducted an inspection of St. Mary's Hospital and Medical Center from June 4 to June 15, 2012, identifying deviations from 21 U.S.C. 351 and 21 CFR Parts 606, 640, and 211.

Violations include: 1. **Failure to maintain Red Blood Cell (RBC) temperature:** RBCs were not consistently stored between 1 and 6°C. The "Packing and Returning of Units Transported on (b)(4) log" showed instances where RBC units, returned as out of range, were subsequently transfused or shipped to other establishments. 2. **Inadequate record-keeping:** The firm failed to concurrently maintain records for storage and distribution of blood units, hindering traceability. Examples include incomplete storage documentation on the (b)(4) log and a unit transfused without storage documentation. 3. **Improper equipment calibration:** Thermometers were not calibrated as per SOPs. On March 6, 2012, three thermometers failed calibration (off by 3-5 degrees) but remained in use. 4. **Insufficient quality control review:** The quality control unit failed to review procedures impacting drug product quality. Numerous (b)(4) logs, despite deviations in shipping/storage temperatures and traceability, lacked a (b)(4) quality review.

The FDA acknowledged the firm's