FDA 483 - Central Admixture Pharmacy Services, Inc. - June 25, 2014

The FDA Form 483 details multiple deficiencies at a drug manufacturing facility. A critical finding is the failure to thoroughly review an unexplained discrepancy, specifically a sterility failure with Aspergillus species in Cardioplegia produced on 5/22/14, leading to a recall. Investigation 13-140528-009 remains in draft form, and despite no identified root cause, the firm continues to produce Cardioplegia and Total Parenteral Nutrition (TPN) using the same processes. Inadequate data was provided to justify limiting the scope of impact to only Cardioplegia.

Key violations include: - **Microbiological Contamination Prevention:** Procedures are not established, written, or followed. Active viable environmental monitoring (EM) is inadequate, not performed every shift in critical areas, not performed dynamically in ISO 5 workstations, and the sampled air volume/conversion to cfu/m3 is inappropriate, leading to uninvestigated excursions. - **Non-Viable Particulate (NVP) EM:** Inadequate, not performed every shift in critical areas, not continuous, sampled volume is insufficient, and sampling location/orientation is not representative of risk. - **Personnel Monitoring:** Inadequate; glove monitoring is not daily, fingertip monitoring technique is not optimized, and gloves are not consistently sanitized. - **Aseptic Practices:** Inadequate; operators' gloved hands were observed above exposed sterile connections in the airflow path, gloves