# FDA 483 - Elite Orthopedics, LLC - July 15, 2025

Source: https://www.keypedia.com/records/483/elite-orthopedics-llc/16eab170-ab84-4fb4-bed9-2ae22f3cba72

> FDA 483 for Elite Orthopedics, LLC on July 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elite Orthopedics, LLC
- Inspection Date: 2025-07-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Elite Orthopedics, LLC in Columbia, MO, an HCTP establishment, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's record-keeping practices, including the use of outdated procedures, failure to maintain equipment documentation and temperature logs, and not following core Current Good Tissue Practices for HCT/Ps. These issues indicate a systemic problem with maintaining proper documentation and adherence to established procedures for human tissue products.

## Related Documents

- [483 - 2025-07-15](https://www.keypedia.com/records/483/elite-orthopedics-llc/aae377e8-a8ff-4fce-bacf-5a72a461fae3)

## Related Officers

- [Esther A. Ofori](https://www.keypedia.com/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)

Company: https://www.keypedia.com/companies/elite-orthopedics-llc/2b9d16d6-5114-4e3b-b1cd-5cc659079254

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8