FDA 483 - Ballard Plaza Pharmacy I, Inc. - May 17, 2016

This FDA Form 483, issued on May 17, 2016, to William G. Ewing, RPh, Owner of Ballard Plaza Pharmacy I, Inc. (FEI 3006317860) in Seattle, WA, details observations from an inspection conducted from April 25-28, May 2-3, and May 17, 2016. The firm is identified as a producer of sterile drug products.

**Key Observations:**

1. **Deficient Aseptic Processing Areas (Cleaning/Disinfection):** * A detached wood panel exposing uncleanable fibrous material in the laminar flow hood (LFH). * Use of non-sterile wipes for cleaning ISO 5 LFH, ISO 7 clean room, and ISO 8 anteroom surfaces. * Apparent soiled material on the LFH pre-filter grate. * Rust on a mobile cart in the ISO 7 clean room. * Soiled telephone handset in the ISO 7 clean room. * Residue on classified area sides of glass windows. * An eight-inch crack on a glass window between the ISO 8 anteroom and ISO 7 clean room.

2. **Inadequate Sterilization Process Validation:** * No bioburden limits established for sterilization processes.