Loading…
Centaur Pharmaceuticals Private Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical drugs following an FDA inspection in January-February 2023. The company failed to adequately clean, maintain, and sanitize manufacturing equipment and utensils, with inspectors identifying residues of different products on direct and indirect product contact surfaces and discovering that certain equipment sections had not been cleaned or examined for cleanliness in over 14 years. These deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as their methods, facilities, and controls did not conform to required manufacturing standards.