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

Source: https://www.keypedia.com/records/483/legacy-ortho-llc/3b7de6e5-0034-4ffc-94ff-933a570d7405

> 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: An FDA inspection, conducted from October 22 to October 29, 2024, at an unspecified facility, identified four significant observations related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection, performed by Investigator Jennifer L Sheehan, highlighted critical deficiencies in adherence to Current Good Tissue Practice (CGTP) requirements. The primary issues observed centered on inadequate record-keeping and a systemic lack of established written procedures. Specifically, the firm failed to record essential information for HCT/Ps stored on site. Furthermore, comprehensive standard operating procedures were not in place for various core manufacturing steps involving HCT/Ps, including specific processing activities. A notable omission was the absence of established procedures for handling complaints, which is a fundamental CGTP requirement. The inspection also revealed a lack of documented procedures for other key activities related to HCT/Ps. These observations underscore a need for the firm to implement robust quality system improvements. This includes developing and formalizing comprehensive documentation practices and establishing clear, written procedures across all HCT/P operations to ensure regulatory compliance. The firm is expected to address these findings with appropriate corrective actions.

## Related Officers

- [Mark L. Baum](https://www.keypedia.com/people/mark-l-baum/03c8bd98-912b-43f9-9e41-6ffb00bc3cfe)
- [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/a197a53f-7348-4578-b8a1-bc6b4ef42389

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