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

Island Kinetics, Inc. d.b.a. CoValence Laboratories in Chandler, AZ, was cited for significant repeat violations during an FDA inspection. The firm failed to establish adequate production and process controls, thoroughly investigate discrepancies and out-of-specification results, and properly maintain and qualify equipment. These issues indicate a systemic lack of control over manufacturing processes and quality systems, posing a risk to drug product quality and purity.