FDA 483 - Cosmetica Laboratories Inc. - June 01, 2018

An FDA inspection of Cosmetica Laboratories Inc., an OTC drug manufacturer in Scarborough, revealed significant deficiencies in quality control and equipment qualification. The firm's quality unit failed to adequately review production records and investigate errors, including improper raw material weighing and inaccurate yield calculations. Additionally, manufacturing equipment was not appropriately designed or qualified for its intended use, impacting process validation and product quality.