FDA 483 - Hi-Tech Pharmaceuticals Inc. - March 24, 2023

Hi-Tech Pharmaceuticals Inc. received a Form 483 citing multiple significant deficiencies in its quality control and manufacturing processes for dietary supplements. Key issues include releasing products with non-conforming components and out-of-specification results, inadequate labeling, insufficient identity testing, and a lack of scientifically valid test methods and proper supplier qualification. Many of these observations are repeats from previous inspections, indicating persistent compliance problems.