FDA 483 - Island Kinetics, Inc. d.b.a. CoValence Laboratories - January 23, 2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories, a drug manufacturer in Chandler, AZ, received a Form 483 with multiple repeat observations during an FDA inspection. The firm was cited for significant failures in establishing adequate production and process controls, thoroughly investigating discrepancies and out-of-specification results, and properly maintaining and cleaning equipment. These deficiencies indicate a lack of control over manufacturing processes and potential risks to the quality and purity of their OTC drug products.