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Sure-Biochem Laboratories, LLC, a contract testing laboratory in Camden, NJ, was cited for significant Current Good Manufacturing Practice (CGMP) violations related to microbial testing of finished drugs. During an FDA inspection in September-October 2022, investigators found that the company failed to establish and follow proper laboratory control mechanisms, including inadequate growth promotion testing of microbiological media with inappropriate challenge conditions and acceptance criteria. These deficiencies resulted in tested drugs being deemed adulterated under the Federal Food, Drug, and Cosmetic Act because the firm's methods, facilities, and controls did not conform to required pharmaceutical manufacturing standards.