FDA 483 - Microvascular Tissue, Inc - April 08, 2025

An FDA inspection of Microvascular Tissue, Inc. in San Diego, CA, revealed significant deficiencies in their quality system for the biological product mVASC. Observations included inadequate complaint investigations, unvalidated manufacturing processes, and a lack of identity testing for drug product components. The firm also failed to thoroughly review batches that did not meet specifications.