# FDA 483 - American Regent Inc. - July 26, 2019

Source: https://www.globalkeysolutions.net/records/483/american-regent-inc/ace94cc9-3260-4e36-ad7d-dafe66ee1c97

> FDA 483 for American Regent Inc. on July 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Regent Inc.
- Inspection Date: 2019-07-26
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: American Regent Inc. in Hilliard, OH, a drug manufacturer, was cited for failing to adequately investigate out-of-specification stability results for a distributed drug batch. The inspection also revealed that the firm did not follow its own written production and process control procedures. This included deficiencies in biennial SOP reviews and documentation of cleaning activities in the sterile manufacturing plant.

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## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.globalkeysolutions.net/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

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