# FDA 483 - ABC Compounding Co., Inc. - April 21, 2023

Source: https://www.keypedia.com/records/483/abc-compounding-co-inc/44fa8c31-b059-43fc-a0fd-a1ae56d5e01e

> FDA 483 for ABC Compounding Co., Inc. on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ABC Compounding Co., Inc.
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: ABC Compounding Co., Inc. in Conyers, GA, an OTC drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. Key issues include releasing drug products that failed microbial specifications after repeated retesting, inadequate reprocessing procedures, and a lack of proper laboratory controls for raw material testing and supplier qualification. The firm also failed to validate its water system, establish expiration dates, maintain written quality control procedures, and implement a robust stability program.

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Senior Manager, Executive Secretariat ](https://www.keypedia.com/people/jessica-m-simpson/94c06709-45cf-464f-92b4-ad3601ea20ab)
- [Program Coordinator](https://www.keypedia.com/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)

Company: https://www.keypedia.com/companies/abc-compounding-co-inc/ffd26af1-9fee-4ed0-acf0-9a4ac91014c2

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