FDA 483 - Central Admixture Pharmacy Services, Inc. - March 30, 2023

The FDA Form 483 details significant deficiencies at a facility producing sterile drug products, specifically concerning quality control, manufacturing processes, and data integrity.

**Violations and Observations:**

* **Inadequate Investigations into Discrepancies:** The firm failed to thoroughly investigate unexplained discrepancies, particularly regarding mold and spore-forming microorganisms (Penicillium chrysogenum, Nigrospora species, Chaetomium globosum, Klebsiella oxytoca) identified in ISO 5 cleanroom environmental monitoring (EM) and personnel monitoring (PM) samples from November 2022 to February 2023. Despite these findings, affected sterile drug product lots were released for distribution without identifying the source of contamination or conducting thorough investigations. * **Lack of Root Cause Analysis and CAPA:** The firm failed to conduct investigations into the root causes of recurring microbial recoveries (bacteria, yeast, molds, spore-forming organisms) in ISO 5 critical zones from 2022 to March 2023. Consequently, adequate corrective and preventative actions (CAPA) were not implemented, yet sterile injectable drug products continued to be manufactured and distributed from these affected areas. Examples include lots produced concurrently with observations of Micrococcus luteus, Brevibacterium species, Bacillus licheniformis, and Staphylococcus hominis. * **Deficient Sterility Testing Procedures:** * The firm uses an alternative sterility test method (b)(4) with