FDA 483 - National Chemical Laboratories - November 04, 2021

National Chemical Laboratories, a finished drug manufacturer in Philadelphia, PA, received a Form 483 for multiple deficiencies in its manufacturing processes for OTC drug products. The observations highlight a widespread lack of written procedures for quality control, production, process validation, equipment maintenance, and stability testing. Additionally, the firm failed to adequately test active ingredients and properly store reserve samples, indicating significant non-compliance with good manufacturing practices.