FDA 483 - Musculoskeletal Transplant Foundation, Inc. - May 19, 2014

The FDA Form 483 document details multiple violations at a facility processing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically Osteochondral Grafts (OC) and Osteoarticular Grafts (OA).

Key violations include: 1. **Contamination Risk and Lack of Validation:** HCT/Ps were not processed to prevent contamination or cross-contamination. The validation for OC and OA Grafts was deficient. For OC Grafts, protocol PV-028 was not followed, with fewer bags tested for sterility than required and syringes not tested. For OA Grafts, protocol 2005I5801-01's acceptance criteria were not met, as treated tissue still showed test organism growth. 2. **Labeling Deficiencies:** Labeling procedures failed to ensure proper HCT/P identification and prevent mix-ups. Issues included lack of verification for donor numbers linked to work orders, incorrect donor numbers on in-process labels used to identify tissue, and misidentification of tissue during sampling. 3. **Inadequate Quality Program and Corrective Actions:** The quality program did not ensure appropriate corrective actions for core CGTP requirements. Deficiencies from complaints were not entered into CAPA or nonconformance systems, and root cause analyses were not performed (e.g., cracked blister packs, granules outside packaging). An ITCCD was generated to link work orders and donor numbers