Microvascular Tissue, Inc.

Warning LetterOpen

Glen G. Gong, PhD Chief Executive Officer Microvascular Tissue, Inc. 6199 Cornerstone Court East, Suite 109 San Diego , CA 92121 United States ggong@mvtissues.comFEI 3011742679Issued Dec 3, 2025Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011742679.

Violations8

Issue DateDec 3, 2025

Product TypeBiologics

StatusOpen

Letter Details

Firm: Microvascular Tissue, Inc.
Location: Glen G. Gong, PhD Chief Executive Officer Microvascular Tissue, Inc. 6199 Cornerstone Court East, Suite 109 San Diego , CA 92121 United States ggong@mvtissues.com
FEI Number: 3011742679
Country: United States
Issue Date: December 03, 2025
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

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.

Microvascular Tissue, Inc. FDA Warning Letter, December 3, 2025