FDA 483 - Potter's House Apothecary, Inc. - September 16, 2020

An FDA inspection of Potter's House Apothecary, Inc. in Peoria, AZ, a producer of sterile and non-sterile drugs, revealed significant deficiencies in aseptic processing. Observations included inadequate cleaning and disinfection systems, personnel making direct product contact, and a failure to certify ISO-5 areas under dynamic conditions. The firm also failed to perform media fills that accurately simulate worst-case aseptic production operations.