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Gadal Laboratories Inc., a drug manufacturer in Miami, Florida, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceuticals, including pediatric over-the-counter products. The company failed to validate and establish the reliability of component suppliers' test analyses at appropriate intervals, specifically using an unqualified supplier for an active ingredient and approving components without properly establishing the credibility of supplier certificates of analysis. The FDA determined that the company's inadequate response to initial findings did not demonstrate a detailed plan for appropriately validating supplier testing or explaining whether all tests on supplier certificates of analysis would be validated, rendering the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.