# FDA 483 - Osteolife Biomedical I LLC - February 14, 2023

Source: https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/7826a380-a81e-424c-bc75-8f659fa18bf9

> FDA 483 for Osteolife Biomedical I LLC on February 14, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osteolife Biomedical I LLC
- Inspection Date: 2023-02-14
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Osteolife Biomedical I LLC, a human tissue processor in Miami, FL, was inspected by the FDA from February 6-14, 2023. The inspection revealed a significant issue with process validation, specifically concerning the bioburden determination for recently revalidated aseptic bone products. This indicates a failure to ensure that critical manufacturing processes are adequately controlled and verified.

## Related Documents

- [483 - 2022-02-04](https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/cec4e92c-49e4-4e6c-b669-0fa75e50103a)
- [WARNING_LETTER - 2022-02-04](https://www.globalkeysolutions.net/records/warning_letter/osteolife-biomedical-i-llc/24458929-f02e-481c-af69-9cb14309ebbb)

## Related Officers

- [Ivan E. Reyes](https://www.globalkeysolutions.net/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)

Company: https://www.globalkeysolutions.net/companies/osteolife-biomedical-i-llc/65c313b4-28a5-4ecc-875c-ac366081fdc2

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6