FDA 483 - BRS Analytical Services, LLC - March 26, 2025

BRS Analytical Services, LLC, a drug manufacturer in Saint Louis, MO, was inspected by the FDA, revealing significant deficiencies across its sterile drug product manufacturing operations. The firm failed to maintain adequate aseptic processing environments, validate critical processes like sterilization and media fills, and establish robust laboratory controls. Furthermore, the quality control unit demonstrated systemic failures in oversight, record-keeping, and adherence to fundamental GMP principles.