Central Admixture Pharmacy Services, Inc. – FDA Warning Letter, Mar 30, 2023

The FDA issued a Warning Letter to CAPS Allentown, an outsourcing facility, following an inspection from February 27 to March 30, 2023. The inspection revealed serious deficiencies in producing sterile drug products, leading to a voluntary recall initiated on April 28, 2023, due to lack of sterility assurance.

The facility's drug products were deemed adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. Violations included insanitary conditions, specifically inadequate product evaluation and corrective action after microbial contamination in the ISO 5 aseptic processing area. Additionally, CGMP violations were cited: failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192) and failure to establish adequate laboratory controls for specifications and testing (21 CFR 211.160(b)).

The FDA found the firm's corrective actions deficient, noting that the procedure for investigating microbial contamination was inadequate and that current environmental monitoring results were not provided. Furthermore, the firm failed to demonstrate the suitability of its rapid sterility test method. The FDA strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with assistance from a third-party consultant.

The letter highlighted repeat CGMP deficiencies and insanitary conditions at other CAPS facilities (Phoenix and San Diego), indicating inadequate management oversight. The firm must respond within fifteen working days with