Consolidated Chemical, Inc – FDA 483, Aug 2, 2022

An FDA inspection of Consolidated Chemical, Inc. DBA CARETECH Laboratories, Inc. in St. Louis, MO, a drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate procedures for preventing objectionable microorganisms, poor facility maintenance with leaks and exposed wiring, and corroded manufacturing equipment. Additionally, the firm failed to follow its written stability testing program and did not properly record or justify deviations from procedures.