FDA 483 - C. B. Fleet Company, Inc. - December 01, 2023

C. B. Fleet, Inc. dba Fleet Laboratories, a drug product manufacturer in Lynchburg, VA, was cited for significant deficiencies in equipment qualification, discrepancy investigations, and preventive maintenance. The inspection revealed unqualified packaging line equipment, a failure to investigate 80 complaints of drug product container leaks, and a systemic issue with overdue equipment maintenance. These issues indicate a lack of control over critical manufacturing and quality processes.