FDA 483 - Central Admixture Pharmacy Services, Inc. - November 20, 2015

This FDA Form 483 details multiple violations observed during an inspection of a sterile drug production facility.

**Facility and Operations:** The facility produces sterile drug products in ISO 5 and ISO 7 classified rooms.

**Violations and Observations:**

* **Microbiological Contamination Prevention (21 CFR 211.42(c)(10)):** * Employees in ISO 5 workstations had exposed eyebrows and facial skin. * Dirt and grime were observed on equipment handles under an ISO 5 hood during production. * **Personnel Gowning (21 CFR 211.28(a)):** * Employees were allowed to exit and re-enter the cleanroom suite for breaks without re-gowning, contrary to SOP 40000171. * **Contamination Prevention (21 CFR 211.42(b)):** * A cleaning tool (b4) was left hanging on a trash can, used for cleaning before entering ISO 7 areas, and its usage times were not logged. * Uncontrolled components were stored in the ISO 7 area near an ISO 5 workstation. * **Building Maintenance (21 CFR 211.58):** * Paint chips and dark rust were present on hooks in ISO 5 workstations near sterile drug components and T