# FDA 483 - Osteolife Biomedical I LLC - February 04, 2022

Source: https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/cec4e92c-49e4-4e6c-b669-0fa75e50103a

> FDA 483 for Osteolife Biomedical I LLC on February 04, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osteolife Biomedical I LLC
- Inspection Date: 2022-02-04
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Osteolife Biomedical I LLC, a human tissue processor in Miami, FL, revealed significant and repeat deficiencies in their manufacturing processes for HCT/Ps, particularly particulate bone products. The firm failed to prevent communicable disease transmission, adequately validate processes, monitor environmental conditions, and properly investigate deviations, leading to the distribution of contaminated products. These issues indicate a severe lack of control over contamination and a deficient quality program.

## Related Documents

- [WARNING_LETTER - 2022-02-04](https://www.globalkeysolutions.net/records/warning_letter/osteolife-biomedical-i-llc/24458929-f02e-481c-af69-9cb14309ebbb)
- [483 - 2023-02-14](https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/7826a380-a81e-424c-bc75-8f659fa18bf9)

## 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