Tanvex BioPharma USA, Inc – FDA 483, May 4, 2022

An FDA inspection of Tanvex BioPharma USA, Inc. in San Diego, a drug substance manufacturer, revealed significant deficiencies across its quality system. Observations included inadequate quality unit oversight, uncontrolled quality control tests, lack of detailed written procedures, and insufficient control to prevent microbial contamination. The firm also failed to follow its own procedures for retesting, equipment status, logbook review, supplier qualification, and deviation reporting, with some issues being repeat observations.