# FDA 483 - Piedmont Hosp Inc - February 18, 2020

Source: https://www.keypedia.com/records/483/piedmont-hosp-inc/ed194bfd-e3b0-42c2-98d9-14a36c1ce250

> FDA 483 for Piedmont Hosp Inc on February 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piedmont Hosp Inc
- Inspection Date: 2020-02-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

## Related Documents

- [STATE_REFERRAL_LETTER - 2020-02-04](https://www.keypedia.com/records/state_referral_letter/piedmont-hosp-inc/41288767-560d-4c60-a6da-0da69843613e)
- [483 - 2020-02-18](https://www.keypedia.com/records/483/piedmont-hosp-inc/15e18fab-ea36-4751-b17f-de1546be3ae7)

## Related Officers

- [Kemejumaka N. Opara](https://www.keypedia.com/people/kemejumaka-n-opara/3f9219f1-13ab-49d7-99fe-5a683e351cd4)
- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.keypedia.com/companies/piedmont-hosp-inc/fb45e812-6082-4408-9009-3ba14f46213b

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7