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

Source: https://www.keypedia.com/records/483/aeon-biotherapeutics-corp/d3e86f9b-1ccd-44b5-ba6a-207857983170

> FDA 483 for Aeon Biotherapeutics Corp. on March 07, 2025. Product: device. 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: device
- Office Name: Division of Blood Components and Devices
- Summary: Aeon Biotherapeutics Corp., a manufacturer in New Taipei City, Taiwan, was inspected by the FDA from March 3-7, 2025. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, control of nonconforming products, and contamination prevention procedures. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.

## Related Documents

- [483 - 2025-03-07](https://www.keypedia.com/records/483/aeon-biotherapeutics-corp/77b83ef6-9699-483c-b943-7bc82efbde63)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Nisha C. Patel](https://www.keypedia.com/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917