# FDA 483 - American Regent Inc. - July 20, 2023

Source: https://www.globalkeysolutions.net/records/483/american-regent-inc/1b739e8a-3e1f-409e-94ce-877349179bc0

> FDA 483 for American Regent Inc. on July 20, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Regent Inc.
- Inspection Date: 2023-07-20
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: American Regent Inc. in Hilliard, OH, a manufacturer of sterile drugs, was inspected by the FDA from July 10-20, 2023. The inspection revealed significant deficiencies in production and process control procedures, as well as failures within the quality control unit. These issues indicate a lack of adherence to good manufacturing practices and proper documentation.

## Related Documents

- [483 - 2019-07-26](https://www.globalkeysolutions.net/records/483/american-regent-inc/ace94cc9-3260-4e36-ad7d-dafe66ee1c97)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)
- [Andrew J. Barrowcliff](https://www.globalkeysolutions.net/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

Company: https://www.globalkeysolutions.net/companies/american-regent-inc/36234cc5-6f5f-4a82-8c32-5aa05715b722

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22