FDA 483 - Piedmont Hosp Inc - February 18, 2020

An FDA inspection of Piedmont Hospital, Inc. dba Phcy-Corp in Atlanta, GA, identified a critical issue within its aseptic processing operations. The firm was cited because disinfecting agents and cleaning wipes used in ISO 5 classified aseptic processing areas, specifically for sterile compounding hoods, were not sterile, which is crucial for maintaining the sterility of compounded drug products.