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OsteoLife Biomedical I LLC, a biologics manufacturer of Freeze-Dried Particulate Bone products, failed to prevent contamination and cross-contamination during processing of human cellular and tissue-based products in violation of 21 CFR 1271.220(a). The company processed multiple batches from single donors on the same day using identical equipment and technicians without performing cleaning between batches, resulting in post-processing cultures that tested positive for microorganisms including Bacillus species on multiple occasions. Despite detecting positive microbiological cultures in some batches, the company distributed other batches from the same donors, creating a significant communicable disease transmission risk.