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Macsen Drugs, an API manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their active pharmaceutical ingredients adulterated. During a September 2024 inspection, the FDA identified critical failures in the quality unit's oversight, including the release of multiple lots of APIs to the U.S. market that had been exposed to improper storage conditions and impacted by a December 2022 facility fire in Block (b)(4). The company's attempt to justify product safety through recreated worst-case testing was deemed inadequate by the FDA, and the quality unit failed to ensure compliance with manufacturing standards before releasing affected lots for distribution.