# FDA 483 - American Regent, Inc. - September 30, 2022

Source: https://www.keypedia.com/records/483/american-regent-inc/41fdc308-c31e-4dc1-85dd-35447b9fb546

> FDA 483 for American Regent, Inc. on September 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Regent, Inc.
- Inspection Date: 2022-09-30
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: American Regent, Inc. in New Albany, OH, a sterile drug manufacturer, was cited for deficiencies within its quality control unit. The firm failed to fully follow its responsibilities and procedures, including making modifications to a visual inspection booth without change control. Additionally, the company did not investigate HEPA recertification failures and had multiple documentation errors in quality records.

## Related Documents

- [483 - 2022-12-09](https://www.keypedia.com/records/483/american-regent-inc/9adb733f-878c-4f1c-9a50-ea09b69cdfc4)

## Related Officers

- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

Company: https://www.keypedia.com/companies/american-regent-inc/9b0566f1-267d-4394-ad2b-cbd7f30b3778

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