Central Admixture Pharmacy Services, Inc. – FDA 483, Jan 29, 2013

The FDA Form 483 details numerous deficiencies at a facility manufacturing sterile injectable drug products, including continuous renal replacement therapy (CRRT) and Ranitidine.

**Key Violations and Observations:**

* **Sterility Testing:** Inadequate sterility testing of finished product batches; only 20% of batches were tested from June to December 2012, with no justification for testing only the last batch of the day. Products were released before sterility test completion, leading to patient use of a failed CRRT batch (24-325144). Ranitidine lots were never tested for sterility. * **Endotoxin Testing:** No testing for bacterial endotoxin in finished sterile drug product lots after aseptic manual filling. * **Microbial Control:** Lack of microbial reduction/control steps, specifically no evaluation of product impact from the absence of a microbial reduction filter after numerous manual aseptic manipulations. * **Inadequate Investigations:** * Sterility failure for CRRT lot 24-325144 (Bacillus licheniformis and Bacillus circulans) was inadequately investigated; root cause not determined, no additional cleaning or environmental monitoring, and no impact assessment for other products made in the same hoods. * Growth on routine air bioburden samples (Staphylococcus epidermidis and Staphylococcus capitis) in clean rooms was not adequately investigated; root cause not determined, and the investigation scope was limited