# FDA 483 - Operating Room Innovations, Inc - May 22, 2025

Source: https://www.keypedia.com/records/483/operating-room-innovations-inc/25c8f396-2b97-49a7-8a90-2c42c4845694

> FDA 483 for Operating Room Innovations, Inc on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Operating Room Innovations, Inc
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Operating Room Innovations, Inc. in La Jolla, CA, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for complaint handling, design changes, corrective and preventive actions, and control of purchased products and services. These issues indicate a systemic lack of robust quality management for its medical devices.

## Related Officers

- [Scott D. Stevens](https://www.keypedia.com/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)

Company: https://www.keypedia.com/companies/operating-room-innovations-inc/8ce1198e-0d28-4ef6-8ac9-4bfaecbf829e

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