FDA 483 - Invicta Nutraceuticals LLC - October 21, 2025

An FDA inspection of INVICTA NUTRACEUTICALS in West Chester, OH, revealed significant deficiencies in their manufacturing operations. The firm failed to establish and follow adequate quality control procedures, maintain comprehensive documentation for drug product manufacturing, and conduct proper stability testing. Additionally, the inspection found that the company did not perform required laboratory testing for active ingredient identity and strength before product release, nor did it verify the identity of incoming components, relying solely on supplier COAs.