FDA 483 - Central Admixture Pharmacy Services, Inc. - August 08, 2014

The FDA inspection of Central Admixture Pharmacy Services (CAPS) San Diego revealed multiple deficiencies in their manufacturing and quality control processes for sterile human drug products.

**Key Violations and Observations:**

* **Inadequate Product Release Testing:** The firm released drug products (Midazolam, Glycopyrrolate, Vecuronium) without performing required sterility and endotoxin testing for every batch, contrary to their own SOP # TP-CAPS-400037. * **Insufficient Aseptic Process Validation:** Aseptic production procedures were not adequately validated through media fills. The media fill simulations did not accurately reflect the number of aseptic connections occurring during actual manufacturing, as evidenced by specific batch examples (Hydromorphone, Morphine). * **Deficient Environmental Monitoring:** The firm failed to adequately monitor bio-burden in Laminar Air Flow hoods, cleanrooms, and personnel. Monitoring was not performed for every batch or shift, and microbial growth from ISO 5 surfaces and personnel samples between January and July 2014 was not investigated. * **Improper Personnel Gowning:** Pharmacy technicians performing aseptic processing did not adequately cover their faces (eyes, eyelashes, eyebrows) or shoes, exposing skin and facility shoes, which violates SOP-CAPS-4000171. * **Inadequate Beyond Use Date (BUD) Studies:** The firm's BUD studies were insufficient, lacking endotoxin