FDA Flags Compliance Issues at Alkem Laboratories' Daman Facility

FDA Flags Compliance Issues at Alkem Laboratories’ Daman Facility

The United States Food and Drug Administration (FDA) has identified regulatory violations at Alkem Laboratories’ manufacturing facility in Daman, India, following a comprehensive 12-day inspection that concluded on May 1. The audit, which began on April 20, resulted in formal observations from federal inspectors, though the company has not yet disclosed the specific nature of…

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