FDA 483 - Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe - July 02, 2021

An FDA inspection of Caribe Holdings (Cayman) Co. Ltd dba Puracap Caribe in Dorado, PR, revealed significant deficiencies across multiple quality systems. The firm's stability program was found to be inadequate and not followed, with issues in container-closure testing and stability study execution. Additionally, the inspection identified problems with laboratory controls, facility maintenance, equipment cleaning, and the handling of rejected materials, indicating a broad lack of adherence to established procedures and good manufacturing practices.