FDA 483 - Central Admixture Pharmacy Services, Inc. - May 04, 2022

This FDA Form 483 was issued to Central Admixture Pharmacy Services, Inc., a producer of sterile drugs located at 410 Commerce Park Drive, Cranberry Township, PA 16066. The inspection occurred from April 26, 2022, to May 4, 2022.

Four observations were noted:

1. **Aseptic Manipulation Issues:** Personnel blocked first-pass air flow in the ISO 5 Laminar Air Flow (LAF) bench during aseptic manipulations. This included inserting syringes into vials, making additions from bags, reaching over open product vials, and stacking empty syringes in a plastic bin, all obstructing critical areas from receiving proper air flow.

2. **Non-Sterile Disinfecting Agents:** Non-sterile disinfecting agents and cleaning wipes were used in ISO 5 classified aseptic processing areas. Employees were observed spraying sterile wipes with non-sterile solutions to clean work surfaces and equipment inside the ISO 5 LAF benches.

3. **Facility Design Flaw:** The facility design permits the influx of lesser quality air into a higher quality air area. An open slot (approximately [redacted] in height and [redacted] in length) along the North side of the ISO 7 production room opened directly to a non-classified pharmacy area, connected to a conveyor belt. This condition was not included in any smoke study validation.

4. **Deficient