FDA 483 - LBB Specialties Holdings LLC - June 26, 2019

An FDA inspection of American International Chemical, LLC in Framingham, MA, in June 2019, revealed inadequate quality oversight concerning drug products. The firm distributed out-of-specification Urea, USP, and failed to conduct a thorough investigation into the product quality and potential impact of the impurity. This indicates a significant lapse in quality control for distributed drug products.