Wise Pharmacy – FDA 483, May 23, 2017

On May 23, 2017, the FDA issued a Form 483 to Joe Wise Pharmacy, Inc. in Littleton, CO, following an inspection from May 8-23, 2017. The firm is a producer of sterile and non-sterile drugs.

The inspection revealed several observations related to sterile drug production:

1. **Non-Sterile Disinfecting Agents and Wipes:** Disinfecting agents and wipes used in the ISO 5 zone were not sterile. Specifically, wipes used with a sanitizing agent and a disinfectant used inside a biological safety cabinet were not sterile. 2. **Non-Sterile Gloves:** Personnel engaged in aseptic processing were observed wearing non-sterile gloves. Additionally, a specific assembly within a biological safety cabinet was not identified as sterile, and no sporicidal treatment was performed on it prior to sterile drug production. 3. **Lack of Pressure Differential Monitoring:** Pressure differentials between areas with different air classifications were not monitored. An instance was observed where a pharmacist cleaned equipment in an unclassified room and then replaced a refuse bag inside the ISO 5 zone, exposing the ISO 5 zone to unclassified air without pressure monitoring. 4. **ISO 5 Area in Non-Classified Room:** The ISO 5 classified area, specifically a biological safety cabinet used for aseptic filling, was located within an unclassified room. 5. **Sinks/