# FDA 483 - Unik Orthopedics, Inc - March 13, 2026

Source: https://www.keypedia.com/records/483/unik-orthopedics-inc/b1cd227f-7e51-4291-bfb9-6a7a15608a38

> FDA 483 for Unik Orthopedics, Inc on March 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unik Orthopedics, Inc
- Inspection Date: 2026-03-13
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Unik Orthopedics, Inc. in San Jose, CA, a manufacturer of orthopedic devices, received a Form FDA 483 with seven observations during an inspection from March 10-13, 2026. The inspection revealed significant deficiencies across its quality management system, including inadequate documentation for risk management, corrective actions, management review, internal audits, supplier controls, complaint investigations, and product identification. These issues indicate a systemic failure to maintain an effective quality system for medical devices.

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.keypedia.com/companies/unik-orthopedics-inc/8a619796-a570-4af6-8d63-0fb0e65d5fc9

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df