FDA 483 - St Mary's Medical Park Pharmacy - December 04, 2025

St Mary's Medical Park Pharmacy, a relabeler and repackager in Oro Valley, AZ, was cited for significant deficiencies across its quality system. The inspection revealed a lack of an independent Quality Unit, inadequate investigation procedures for complaints and deviations, unvalidated production processes, and insufficient environmental monitoring. Furthermore, the firm demonstrated poor control over computer systems, deficient batch records, unrepresentative reserve samples, and inadequate equipment calibration protocols.