FDA 483 - Central Admixture Pharmacy Services. Inc. - January 29, 2016

The FDA Form 483 details multiple deficiencies at a facility producing sterile Total Parenteral Nutrition (TPN) products for adult and pediatric patients.

**Facility and Operations:** The facility includes ISO 5, ISO 7, and ISO 8 clean rooms, with sterile drug production occurring within ISO 5 laminar flow workbenches in Compounding Room #1 (ISO 7).

**Violations and Observations:**

* **Aseptic Conditions & Equipment Maintenance:** * Clean rooms (ISO 5, 7, 8) have not been certified under dynamic conditions since an unspecified date. * Two ISO 5 HEPA filters showed black splotchy patches, and all HEPA filters in ISO 5 and ISO 7 areas had rust-colored screening. * A Sterile redacted designed for redacted containers was used to redacted a component for TPN. * Ceiling light fixtures in Compounding Room #1 (ISO 7) were lifted, creating a 1/2-inch gap. * **Microbiological Contamination Prevention:** * Personnel in the ISO 7 room redacted vials used in TPN production with sterile redacted prior to entering the ISO 5 area, without physical debridement, potentially leaving contaminants. This step is not required by written documentation. * **Facility Design & Space:** * An operator was observed beneath redacted barriers, potentially blocking