FDA EIR - Musculoskeletal Transplant Foundation, Inc., dba MTF Biologics - July 19, 2019

Musculoskeletal Transplant Foundation, Inc. (MTF) in Jessup, PA, underwent an FDA inspection from July 16-19, 2019. This inspection, conducted under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps), assessed MTF's processing of various human tissues including bone, cartilage, and tendons.

Although no formal FDA Form 483 (Inspectional Observations) was issued, the inspection revealed three critical issues discussed with management. Firstly, cleaning operations in processing rooms showed an inconsistency where personnel failed to apply SporKlenz to the USP water valve as mandated by written procedures. Secondly, labels for freeze-dried human tissue products indicated storage at "ambient temperature" without specifying defined temperature ranges, posing a challenge to compliance with 21 CFR 1271.260(e) which requires recording specific storage temperatures. Thirdly, a significant deficiency identified was the absence of an overarching written procedure for base tissue processing, with employees relying on unreferenced Work Elements and Flow Charts, failing to meet 21 CFR 1271.180 for comprehensive manufacturing procedures.

MTF management acknowledged these observations and committed to prompt corrective actions. These included conducting retraining for cleaning personnel, addressing the lack of specific storage temperature limits for freeze-dried products to ensure regulatory compliance, and developing a complete, referenced procedure for base tissue processing.