# American Regent Inc. – FDA 483, Jun 18, 2026

Source: https://www.keypedia.com/records/483/american-regent-inc/96774b9a-8a5e-43f5-b5d5-7ecb941955b0

> FDA 483 for American Regent Inc. on June 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Regent Inc.
- Inspection Date: 2026-06-18
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: American Regent Inc. in Hilliard, OH, was inspected from June 9-18, 2026, and received one observation. The inspection revealed that the firm's quality control unit failed to consistently follow its own procedures for managing quality events, specifically regarding the identification and implementation of Corrective and Preventive Actions (CAPAs) or providing justification when no CAPAs were deemed necessary. This deficiency led to instances of unauthorized raw material release and recurring visible particulate issues without adequate resolution.

## Related Documents

- [483 - 2023-07-20](https://www.keypedia.com/records/483/american-regent-inc/1b739e8a-3e1f-409e-94ce-877349179bc0) — date: July 20, 2023
- [483 - 2019-07-26](https://www.keypedia.com/records/483/american-regent-inc/ace94cc9-3260-4e36-ad7d-dafe66ee1c97) — date: July 26, 2019

## Related Officers

- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

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

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