FDA EIR - Musculoskeletal Transplant Foundation - May 07, 2019

The FDA conducted a routine inspection of Musculoskeletal Transplant Foundation (MTF) in Rochester, NY, from May 6-7, 2019. Operating as a satellite tissue recovery facility, MTF is a registered Human Cell and Tissue Establishment involved in the recovery and distribution of tissues such as bone, tendons, ligaments, and skin, and was preparing to recover amniotic membrane. The inspection followed the Compliance Program for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and verified the firm's registration.

The scope of the inspection included a thorough review of donor eligibility determinations, including medical and social histories, serology test results, and hospital records. Additionally, the storage and quality assurance procedures for supplies and reagents used in tissue recovery were assessed. The facility demonstrated adequate practices, including addressing FDA's Zika virus recommendations for donor screening.

Crucially, the inspection concluded with no main violations or deficiencies identified. No FDA Form 483, Inspectional Observations, was issued to MTF Rochester, indicating overall compliance with regulatory standards. During the closeout meeting, management received a general reminder about maintaining registration and the potential regulatory sanctions under PHS Section 351 for non-compliance, but no specific corrective actions were mandated for the facility.