# FDA 483 - OsteoCentric Technologies, Inc. - November 13, 2023

Source: https://www.globalkeysolutions.net/records/483/osteocentric-technologies-inc/92673121-207b-4edf-beb8-885e3d63bb57

> FDA 483 for OsteoCentric Technologies, Inc. on November 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OsteoCentric Technologies, Inc.
- Inspection Date: 2023-11-13
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of OsteoCentric Technologies, Inc. in Logan, UT, a medical device specification developer, revealed significant deficiencies in its quality system. The firm failed to submit a Medical Device Report for a serious injury, inadequately maintained complaint files, and did not properly document corrective and preventive actions. These issues indicate a lack of robust control over post-market surveillance and quality processes.

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/osteocentric-technologies-inc/e9e655aa-5d15-45bb-9fd4-833dd7593123

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face