OsteoLife Biomedical I LLC

Warning LetterOpen

Theodore I. Malinin, MD Medical Director and Co-Owner OsteoLife Biomedical I LLC 1951 NW 7th Avenue Sanibel Suite Miami , FL 33136 United StatesFEI 3014623896Issued Mar 31, 2022Office of Biological Products Operations – Division I

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Violations4

Issue DateMar 31, 2022

Product TypeBiologics

StatusOpen

Letter Details

Firm: OsteoLife Biomedical I LLC
Location: Theodore I. Malinin, MD Medical Director and Co-Owner OsteoLife Biomedical I LLC 1951 NW 7th Avenue Sanibel Suite Miami , FL 33136 United States
FEI Number: 3014623896
Country: United States
Issue Date: March 31, 2022
Issuing Office: Office of Biological Products Operations – Division I
Product Type: Biologics
Status: Open

Summary

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.

OsteoLife Biomedical I LLC FDA Warning Letter, March 31, 2022