# FDA 483 - American Regent, Inc. - January 29, 2026

Source: https://www.keypedia.com/records/483/american-regent-inc/fe928401-4867-435d-a57c-98c40de6012a

> FDA 483 for American Regent, Inc. on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Regent, Inc.
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: American Regent, Inc. in New Albany, OH, a sterile drug manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into batch failures, sterility issues, and out-of-specification results. Additionally, the firm failed to adequately manage supplier quality and adhere to aseptic manufacturing procedures, indicating a systemic breakdown in their quality management system.

## Related Documents

- [EIR - 2022-09-30](https://www.keypedia.com/records/eir/american-regent-inc/dadc425f-608f-4192-b06c-56d0829febcb)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/american-regent-inc/9adb733f-878c-4f1c-9a50-ea09b69cdfc4)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/american-regent-inc/bb052ee0-e2fb-4896-9245-0e2beb3a7f56)
- [483 - 2022-09-30](https://www.keypedia.com/records/483/american-regent-inc/41fdc308-c31e-4dc1-85dd-35447b9fb546)

## Related Officers

- [company_representative](https://www.keypedia.com/people/nelson-n-ayangho/917cb8ea-904d-41a1-b522-2351d3cb1f74)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Martin M. Kimani](https://www.keypedia.com/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

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