FDA 483 - Island Kinetics, Inc. d.b.a. CoValence Laboratories - January 06, 2020

An FDA inspection of Irland Kinetics, Inc. d.b.a. CoValence Laboratories in Chandler, AZ, revealed significant and systemic deficiencies across its quality, laboratory, and production systems. The firm repeatedly failed to adhere to good manufacturing practices, including distributing out-of-specification drug products, lacking essential written procedures, and having inadequate training and validation programs. Many of these issues were repeat observations from a previous inspection, indicating persistent non-compliance.