# Osseofuse International Inc. – FDA 483, Jan 7, 2026

Source: https://www.keypedia.com/records/483/osseofuse-international-inc/a1c41fd3-2466-401b-8d38-8feccc06b9a7

> FDA 483 for Osseofuse International Inc. on January 07, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osseofuse International Inc.
- Inspection Date: 2026-01-07
- Product Type: device
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Osseofuse International Inc., a specification developer of sterile and non-sterile dental implants and abutments in Las Vegas, NV, revealed significant deficiencies in their quality system. Observations included inadequate procedures for finished device acceptance, specifically regarding sterility verification and record-keeping, as well as undocumented evaluations of contractors. Additionally, the firm lacked established procedures for design changes, leading to uncontrolled documentation of approvals.

## Related Documents

- [483 - 2021-08-26](https://www.keypedia.com/records/483/osseofuse-international-inc/b35004cc-ff38-4cc8-badb-458e3c67437a) — date: August 26, 2021

## Related Officers

- [Linda Galindo](https://www.keypedia.com/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.keypedia.com/companies/osseofuse-international-inc/92b1d1dd-3c9f-4ce7-aa32-2e74c34c848a

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