FDA 483 - Continental Manufacturing Chemist - May 10, 2023

Continental Manufacturing Chemist, an OTC manufacturer in Huxley, IA, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate component testing for impurities, failure to validate supplier analyses, and lack of appropriate controls over computer systems and production records. Additionally, the firm failed to follow written procedures for equipment cleaning and maintenance, leading to visible residue on manufacturing vessels.