# FDA 483 - Aeon Biotherapeutics Corp. - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/aeon-biotherapeutics-corp/77b83ef6-9699-483c-b943-7bc82efbde63

> FDA 483 for Aeon Biotherapeutics Corp. on March 07, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aeon Biotherapeutics Corp.
- Inspection Date: 2025-03-07
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Aeon Biotherapeutics Corp. in New Taipei City, Taiwan, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, insufficient control over nonconforming products, and poorly defined contamination prevention (gowning) procedures. These issues indicate a lack of robust quality management practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/alexander-m-kay/0b791400-16cd-45d9-b39d-ad832a6cbe9a)
- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)
- [Creighton T. Tuzon](https://www.globalkeysolutions.net/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.globalkeysolutions.net/companies/aeon-biotherapeutics-corp/14a7b58b-e4ee-422d-a423-3806fdb8b038

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8