# FDA 483 - Elevate Surgical - March 26, 2026

Source: https://www.keypedia.com/records/483/elevate-surgical/23b89d0e-72d5-4c37-a8ae-bf1feeb31313

> FDA 483 for Elevate Surgical on March 26, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elevate Surgical
- Inspection Date: 2026-03-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Elevate Surgical in San Diego, CA, an HCT/P Storage & Distribution Facility, revealed three significant observations. The firm failed to routinely inspect equipment for maintenance, lacked established procedures for facility cleaning and sanitation, and had an inadequate quality program that did not ensure appropriate CGTP procedures were maintained, reviewed, and revised, particularly concerning temperature monitoring of allografts.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [James A. Banks](https://www.keypedia.com/people/james-a-banks/6838e911-c630-4a7c-8198-f3936ef6c5f8)

Company: https://www.keypedia.com/companies/elevate-surgical/5a4b8675-fd34-4225-b025-bd9ca7976d35

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6