FDA 483 - Central Admixture Pharmacy Services, Inc. - August 18, 2025

An FDA inspection of Central Admixture Pharmacy Services, Inc., an outsourcing facility in Allentown, PA, conducted from August 18 to September 5, 2025, revealed critical deficiencies in its manufacturing and quality control systems. The firm was cited for failing to follow procedures to prevent microbiological contamination, notably by discontinuing continuous particulate monitoring in cleanroom environments and documenting frequent viable microbial excursions. The accuracy and reproducibility of its Microbial Detection System for sterility testing were not adequately established, with deficiencies noted in performance qualification and method transfer studies. Furthermore, the company"s 100% visual inspection process was found to be inadequate, resulting in numerous failures to detect product defects like particulates and leaking bags prior to release. Central Admixture Pharmacy Services also accepted critical incoming components, including active pharmaceutical ingredients, based solely on supplier certificates without performing identity testing or validating supplier analyses. Finally, the firm’s procedure for investigating unexplained discrepancies was deficient, permitting retesting of environmental monitoring samples after alert or action level excursions without initiating necessary investigations. These observations highlight significant deviations from regulatory standards for sterile drug product manufacturing, requiring Central Admixture Pharmacy Services, Inc. to implement comprehensive corrective and preventive actions to ensure product quality and patient safety.