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Talk to a SpecialistTalk to a SpecialistBRS Analytical Services, LLC, a drug manufacturing facility and contract testing laboratory in St. Louis, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of sterile over-the-counter drug products during an FDA inspection in March 2025. The company failed to maintain adequate aseptic processing controls, including fundamental design defects in its ISO 5 cleanroom such as gaps in walls separating it from an unclassified warehouse area, and failed to use appropriately designed and located equipment for manufacturing and maintaining sterile products. These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as the company's methods, facilities, and controls did not conform to required manufacturing standards.