FDA EIR - Musculoskeletal Transplant Foundation, Inc. - March 09, 2022

The FDA conducted a routine, comprehensive inspection of Musculoskeletal Transplant Foundation, Inc. (MTF Biologics) in Edison, NJ, from February 28 to March 9, 2022. This inspection focused on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under the relevant regulatory framework. Notably, the current inspection concluded without any significant deficiencies being identified or an FDA Form 483 being issued. The report indicated that previously identified deficiencies from a 2017-2018 inspection, which concerned Zika virus screening and documentation, had been fully corrected. Minor issues noted during this inspection were rectified on-site. While this specific inspection was favorable, the document detailed a history of the company's internal nonconformance reports and recalls, demonstrating ongoing compliance efforts. These included issues like incorrect media preparation for sterility testing, failure to place tissue on hold, and the presence of particulates (stainless steel and rubber) in prehydrated adipose products, which led to enhanced preventive maintenance and procedural updates. Recent recalls, some classified as Class 1, stemmed from errors in quality review processes regarding non-conforming organisms, and issues with donor eligibility assessments, including cases of sepsis and updated donor risk information. MTF Biologics implemented extensive corrective actions for these incidents, such as revising procedures, reconfiguring computer systems, and comprehensive staff retraining, to prevent recurrence and ensure product safety.