FDA 483 - Central Admixture Pharmacy Services. Inc. - February 19, 2013

The FDA Form 483 details observations from an inspection of a facility that performs manual aseptic manipulations for filling sterile injectable drug products.

**Key Violations and Observations:**

* **Sterility Testing Deficiencies:** The firm does not test all finished product batches for sterility, only 56% of batches manufactured between November and December 2012 were tested. Products are released for patient use before sterility test completion. * **Lack of Endotoxin Testing:** Final units are not tested for bacterial endotoxin after aseptic manual filling. * **Inadequate Microbial Control:** There is a lack of microbial reduction/control steps, and the product impact of not using a microbial reduction filter after numerous manual aseptic manipulations has not been evaluated. * **Quality Unit Failures:** * Failure to adequately investigate sterility failures (e.g., Potassium phosphate batch 27-144225 and Oxytocin 20 units in Lactated Ringer batch 27-196244), including root cause analysis, corrective actions, and extension of investigations to associated batches. * Failure to investigate and implement corrective actions for environmental investigations upon reaching action limits in classified areas (ISO 5 and ISO 7). * Failure to investigate approximately 241 microbiological isolates from critical areas (ISO 5 and personnel) in 2011-2012, including identification and impact