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Bi-Coastal Pharma International was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs, rendering their products adulterated. The company failed to establish and follow adequate written procedures for handling drug product complaints and, specifically, failed to adequately investigate a June 2020 complaint regarding an adverse reaction to Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/2.5 mg without initiating the required manufacturing and packaging evaluation. The violations were documented during an FDA inspection conducted from December 15, 2021, to January 14, 2022, at the company's Shrewsbury, New Jersey facility.