# FDA 483 - Legacy Ortho LLC - October 29, 2024

Source: https://www.keypedia.com/records/483/legacy-ortho-llc/80f754b5-176f-4753-a022-19ba05e365ec

> FDA 483 for Legacy Ortho LLC on October 29, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legacy Ortho LLC
- Inspection Date: 2024-10-29
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Legacy Ortho LLC in Mason, OH, received a Form 483 with four observations related to its human tissue establishment. The inspection revealed significant deficiencies in record-keeping and the establishment of core Current Good Tissue Practice (CGTP) procedures, particularly concerning HCT/Ps. These issues indicate a lack of adequate controls for manufacturing, storage, and complaint handling.

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/legacy-ortho-llc/c4e30074-a608-4301-992f-b8e0e107c64f

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22