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

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