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

Source: https://www.keypedia.com/records/483/potters-house-apothecary-inc/c25137d2-5816-4c38-a0cf-52fd34d8afe2

> FDA 483 for Potter's House Apothecary, Inc. on September 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Potter's House Apothecary, Inc.
- Inspection Date: 2020-09-16
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2020-09-16](https://www.keypedia.com/records/483/potters-house-apothecary-inc/a979e01e-675d-4160-a4c9-72edc5820581)
- [STATE_REFERRAL_LETTER - 2020-09-08](https://www.keypedia.com/records/state_referral_letter/potters-house-apothecary-inc/7d539f0a-e12e-41c1-937d-6d064256c863)

## Related Officers

- [Nicholas L. Hunt, Drug Specialist](https://www.keypedia.com/people/nicholas-l-hunt-drug-specialist/e49262e9-fa46-4c44-918f-b3a938471ced)

Company: https://www.keypedia.com/companies/potters-house-apothecary-inc/dd4ede3f-7d4e-4d08-b4b2-c247f51497d3

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face