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

Source: https://www.globalkeysolutions.net/records/warning_letter/osteolife-biomedical-i-llc/24458929-f02e-481c-af69-9cb14309ebbb

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

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Osteolife Biomedical I LLC
- Inspection Date: 2022-02-04
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA issued a Warning Letter to OsteoLife Biomedical I LLC following an inspection from December 6, 2021, to February 4, 2022, which revealed significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include:
1.  **Failure to prevent contamination (21 CFR 1271.220(a))**: Multiple batches of Freeze-Dried Particulate Bone from single donors were processed on the same day with the same equipment and technician without cleaning between batches. Post-processing cultures repeatedly tested positive for microorganisms (e.g., Bacillus, Stenotrophomonas maltophilia, Pseudomonas aeruginosa, Micrococcus luteus), yet other batches from the same donor were distributed. Additionally, a sterile sheet covered the laminar flow bench's return air slots during processing, increasing contamination risk.
2.  **Failure to validate processes (21 CFR 1271.230(a))**: The manufacturing processes for Flexo-Plate, Flexo-Membrane, and Freeze-Dried Particulate Bone products were not adequately validated. Validation reports lacked in-process microbiological testing and acceptance criteria for contamination.
3.  **Failure to monitor environmental conditions (21 CFR 1271.195(c))**: Environmental monitoring for microorganisms was conducted approximately quarterly and not

## Related Documents

- [483 - 2022-02-04](https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/cec4e92c-49e4-4e6c-b669-0fa75e50103a)
- [483 - 2023-02-14](https://www.globalkeysolutions.net/records/483/osteolife-biomedical-i-llc/7826a380-a81e-424c-bc75-8f659fa18bf9)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1