FDA 483 - Hi-Tech Pharmaceuticals Inc. - March 30, 2021

Hi-Tech Pharmaceuticals received a Form 483 for significant deficiencies in their manufacturing and quality control processes for dietary supplements and contract-manufactured protein blends. Key issues include the lack of a food safety plan, failure to control undeclared allergens, and the release of out-of-specification products. The firm also demonstrated inadequate component identity testing, poor documentation, and insufficient complaint handling, indicating systemic failures in adhering to good manufacturing practices and ensuring product quality and safety.