FDA 483 - DSC Laboratories, Inc. - July 16, 2025

DSC Laboratories, Inc. in Muskegon, MI, an OTC drug manufacturer, was cited for significant deficiencies in quality control and manufacturing practices. The inspection revealed issues including inadequate investigations into microbial contamination in water systems, insufficient water system sampling and stability testing, unqualified laboratory standards, poor computer system controls, and improper drug product storage conditions with unaddressed temperature excursions. These observations indicate a lack of robust quality assurance for their OTC drug products.