FDA 483 - University of Washington Inpatient Pharmacy - August 04, 2016

This FDA Form 483 report details observations from an inspection of the University of Washington Medical Center Inpatient Pharmacy, a producer of sterile drug products, located at 1959 NE Pacific St, Box 356015, Seattle, WA 98195. The inspection occurred on various dates between July 11 and August 4, 2016. The report was issued to Shabir M. Somani, Chief Pharmacy Officer.

Key observations include:

1. **Deficient Aseptic Processing Area Cleaning/Disinfection:** Non-sterile wipers with sterile isopropyl alcohol were used to clean ISO 5 laminar flow hoods (LFH), and apparent white debris was observed on an LFH filter grate. 2. **Deficient Aseptic Processing Equipment Maintenance:** Pitting and scratches were observed on LFH workbenches and filter grates, and a wooden door was installed between ISO 8 and ISO 7 rooms. 3. **Inadequate Sterilization Process Validation:** Sterilized containers/utensils were stored for extended, unvalidated periods. Depyrogenation practices for glass beakers and stir bars were inadequate, involving non-sterile wipers. Component wipe-down procedures before introduction into cleanrooms were also inadequate, using non-sterile wipers. LFHs were certified under static conditions but used dynamically without dynamic air pattern analysis (smoke studies) for LFHs and buffer rooms.