FDA 483 - Central Admixture Pharmacy Services, Inc. - August 25, 2023

Central Admixture Pharmacy Services Inc received a Form 483 detailing significant deficiencies in its quality control unit, aseptic processing, and laboratory controls. The observations highlight failures to ensure drug product sterility, purity, and strength, including inadequate investigations into particulate matter, microbial contamination, and adverse drug events. The firm also exhibited poor documentation practices, insufficient environmental monitoring, and facility maintenance issues, indicating a systemic lack of adherence to cGMP regulations for sterile drug production.