FDA EIR - Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics - May 20, 2019

An FDA inspection of Musculoskeletal Transplant Foundation (MTF) in Olyphant, PA, took place on May 20, 2019. The inspection assessed MTF's operations as a human tissue storage and distribution center, falling under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps). While no formal inspectional observations (Form FDA 483) were issued, two significant issues were discussed with management.

First, product labeling for freeze-dried human tissue stated "Store at ambient temperature" but lacked specific temperature ranges. This raised questions about the firm's ability to fully comply with federal regulations (21 CFR 1271.260(e)) requiring the maintenance and recording of precise storage temperatures. Management acknowledged this concern, noting it was a previously discussed topic, and committed to reviewing and implementing specific temperature limits for these products.

Second, an employee was observed packaging freeze-dried human tissue products for distribution prior to scanning them into the QAD inventory system, a procedural error. This was immediately corrected by a supervisor, who also reinforced the proper scanning procedures with the employee. Management affirmed their understanding of the observations and promised corrective actions for both identified areas, indicating a commitment to addressing these operational and labeling clarifications.