# FDA 483 - Overture Resurfacing Inc. DBA Overture Orthopaedics - January 30, 2025

Source: https://www.keypedia.com/records/483/overture-resurfacing-inc-dba-overture-orthopaedics/453347b8-70f3-47c0-9c9c-7d62b1aa4e9c

> FDA 483 for Overture Resurfacing Inc. DBA Overture Orthopaedics on January 30, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Overture Resurfacing Inc. DBA Overture Orthopaedics
- Inspection Date: 2025-01-30
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Overture Resurfacing Inc. DBA Overture Orthopaedics in Irvine, CA, was inspected by the FDA from January 23-30, 2025. The inspection revealed a significant issue regarding the firm's purchasing controls. Specifically, the company failed to establish adequate agreements with critical suppliers for its Class II Knee Resurfacing System device, despite its own procedures requiring such agreements.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/overture-resurfacing-inc-dba-overture-orthopaedics/271f26a3-1867-4b0d-9972-d578c68831a5

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