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Talk to a SpecialistTalk to a SpecialistAntaria Pty. Ltd., an active pharmaceutical ingredient (API) manufacturer in Australia, failed to meet Current Good Manufacturing Practice (CGMP) standards during an FDA inspection in November 2023. The company did not adequately investigate or document out-of-specification (OOS) test results for its API products, including assay and loss on ignition testing, and released lots with OOS results despite quality unit concerns. Root causes of the failures were not clearly defined or documented, and the company's corrective action plan—which blamed staff turnover and insufficient training—was deemed inadequate because it lacked a comprehensive review of all investigations and their adequacy. These deviations rendered the company's API adulterated under the Federal Food, Drug, and Cosmetic Act.