FDA 483 - Green Wave Analytical, LLC - March 07, 2022

An FDA inspection of Green Wave Analytical, LLC in San Diego, CA, a control testing laboratory, from February 15 to March 7, 2022, revealed significant deficiencies in its quality system and laboratory controls. The firm lacked a quality control unit, failed to validate test methods, and exhibited severe issues with equipment calibration and data integrity. These observations indicate a fundamental lack of controls necessary to ensure the safety, identity, strength, purity, and quality of drug products tested.