FDA 483 - ChemRite CoPac, Inc. - July 20, 2023

ChemRite CoPac, Inc. in Lannon, WI, a drug product manufacturer, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in quality unit staffing, laboratory controls for water sampling and testing, equipment maintenance, and the thoroughness of complaint investigations. Furthermore, the firm failed to establish and follow appropriate written procedures for preventing objectionable microorganisms and for equipment cleaning and maintenance.