ChemRite CoPac LLC – FDA 483, Feb 21, 2013

ChemRite CoPac, Inc. in Lannon, WI, received a Form FDA 483 following an inspection of its OTC, medical device, and cosmetic manufacturing operations. The inspection revealed significant deficiencies across quality control, including inadequate control of non-conforming products, unestablished CAPA procedures, lack of MDR procedures, and failures in microbial testing and equipment maintenance. These issues indicate a systemic breakdown in quality management and compliance with regulatory requirements.