# FDA 483 - Limber Prosthetics and Orthotics, Inc - March 20, 2026

Source: https://www.keypedia.com/records/483/limber-prosthetics-and-orthotics-inc/91ed4792-a4ef-496c-97d2-a498770bc707

> FDA 483 for Limber Prosthetics and Orthotics, Inc on March 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Limber Prosthetics and Orthotics, Inc
- Inspection Date: 2026-03-20
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Limber Prosthetics and Orthotics, Inc. in San Diego, CA, was inspected and cited for significant deficiencies in its quality management system. The inspection revealed failures in software validation for prosthetic limb design and manufacturing, inadequate control over outsourced coating processes, and incorrect Unique Device Identifier (UDI) information submitted to the FDA's GUDID. These issues indicate a lack of robust quality controls for a Class II medical device manufacturer.

## Related Officers

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

Company: https://www.keypedia.com/companies/limber-prosthetics-and-orthotics-inc/59006625-a428-49ab-aa98-7448e27f7133

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