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Microvascular Tissue, Inc. was cited for marketing mVASC®, an unapproved allogeneic biological product derived from human hypodermis, without a valid Biologics License Application (BLA) or New Drug Application (NDA), in violation of the Public Health Service Act and Federal Food, Drug, and Cosmetic Act. During an FDA inspection conducted March 31–April 8, 2025, the agency documented significant Current Good Manufacturing Practice (CGMP) violations in the company's manufacturing processes, facilities, and controls, including failures under 21 CFR Parts 210 and 211. The company was advised that continued introduction or delivery of the unlicensed product into interstate commerce is prohibited.