Potter's House Apothecary, Inc.September 16, 2020

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

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Record Details

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.

Company: Potter's House Apothecary, Inc.
Inspection Date: September 16, 2020
Product Type: Drugs
Office: Denver District Office
Person: Nicholas L. Hunt (Senior CSO, Investigator)

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ID · c25137d2-5816-4c38-a0cf-52fd34d8afe2