483
Piedmont Hosp IncFDA 483 - Piedmont Hosp Inc - February 18, 2020
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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.
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ID · ed194bfd-e3b0-42c2-98d9-14a36c1ce250