FDA 483 - C. B. Fleet Company, Inc. - December 01, 2023
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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.
ID · b15c3f8d-57b8-4929-8f2a-32a0034bf065