FDA 483 - Du-Var Laboratory - October 20, 2023

Du-Var Laboratory, a contract manufacturer in Boucherville, was cited with four observations during an FDA inspection from October 12-20, 2023. The inspection revealed significant deficiencies in quality control, including a failure to validate manufacturing and packaging processes for OTC drug products, inadequate cleaning validation, and insufficient investigation of microbial excursions in water samples. These issues indicate a lack of robust quality systems to ensure drug product identity, strength, purity, and quality.