FDA 483 - Central Admixture Pharmacy Services, Inc. - February 25, 2022

Central Admixture Pharmacy Services, Inc. in Phoenix, AZ, an outsourcing facility, was inspected and cited for significant deficiencies across its production, laboratory, facilities, and quality systems. Key issues include inadequate aseptic process validation, poor maintenance of aseptic processing equipment, insufficient laboratory record-keeping for calculations, and a lack of control over computer systems for assay data. Additionally, the firm failed to thoroughly review unexplained discrepancies and maintain sterility testing equipment calibration.