FDA WARNING_LETTER - Musculoskeletal Transplant Foundation - November 30, 2012

The FDA conducted an inspection of Musculoskeletal Transplant Foundation (MTF) in Edison, NJ, from September 17 to November 30, 2012, revealing significant deviations from HCT/P regulations (21 CFR Part 1271).

Key violations include: 1. **Distribution of Non-Compliant HCT/Ps (21 CFR 1271.265(c)(2)):** MTF distributed Trinity products from donors 0031108715 and 0671107306 despite positive sterility tests for *Clostridium perfringens* and *Clostridium sordellii*, respectively. These products, including fresh tissue, bone, and soft tissue allografts, were released after aseptic processing but without required gamma irradiation. 2. **Failure to Establish/Maintain CGTP Procedures (21 CFR 1271.180(a)):** * **Failure to Follow Procedures:** MTF did not follow WI-335 (Quality Assurance First and Second Review) for the aforementioned donors, releasing allografts without gamma irradiation despite positive *Clostridium* sterility results. * **Outdated Procedures:** WI-335 was not timely updated to reflect critical changes from Engineering Memos (40, 50, 56), discontinuation of post-treatment gamma irradiation, and