# FDA 483 - Activbody, Inc. - August 22, 2025

Source: https://www.keypedia.com/records/483/activbody-inc/f077dedc-e611-4e7e-a78a-fffc12a17310

> FDA 483 for Activbody, Inc. on August 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Activbody, Inc.
- Inspection Date: 2025-08-22
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Activbody, Inc. in San Diego, CA, a manufacturer of Class II medical devices, was cited for five significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for design validation, complaint handling, training, and management review. Additionally, Activbody did not register the Unique Device Identifier (UDI) for a Class II medical device in the FDA's GUDID database.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/activbody-inc/df5db145-7e8b-4df3-8d9c-1d6fe638deb3

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b