FDA 483 - AJES Pharmaceuticals, LLC - March 29, 2018

An FDA inspection of AJES Pharmaceuticals LLC in Copiague, NY, a dietary supplement manufacturer, revealed significant deficiencies in quality control. The firm failed to adequately test finished dietary supplements for identity, purity, strength, and composition, and did not establish proper identity specifications for components. These issues, including a repeat observation, indicate a lack of scientific rationale and documentation for ensuring product quality.