FDA 483 - Levlad, LLC - May 19, 2022

An FDA inspection of Levlad, LLC in Chatsworth, CA, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to adequately investigate product complaints and out-of-specification results, did not properly qualify contract laboratories or conduct annual product reviews, and lacked appropriate testing methods and written production controls for drug products. These issues indicate a systemic breakdown in ensuring product quality and purity.