# FDA WARNING_LETTER - Musculoskeletal Transplant Foundation - November 30, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/musculoskeletal-transplant-foundation/7b970298-5c35-469a-820a-ff3cfbbe8b22

> FDA WARNING_LETTER for Musculoskeletal Transplant Foundation on November 30, 2012. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Musculoskeletal Transplant Foundation
- Inspection Date: 2012-11-30
- Product Type: Biologics
- Office Name: New Jersey District Office
- Summary: 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    *   **Outdated Procedures:** WI-335 was not timely updated to reflect critical changes from Engineering Memos (40, 50, 56), discontinuation of post-treatment gamma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

## Related Documents

- [EIR - 2019-05-07](https://www.globalkeysolutions.net/records/eir/musculoskeletal-transplant-foundation/6dc1dc08-0567-47ec-a4d8-185048b495fb)

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.globalkeysolutions.net/companies/musculoskeletal-transplant-foundation/7fd4ddd4-33eb-4119-956a-a0e85d993c01

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248