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

During an inspection conducted from November 27 to December 1, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to C. B. Fleet, Inc. dba Fleet Laboratories, a manufacturer located in Lynchburg, VA. The inspection revealed significant concerns regarding the firm's adherence to current Good Manufacturing Practices (cGMP) for drug products. Key observations included the failure to adequately qualify equipment on a packaging line used for drug products such as Fleet Enema, indicating a lack of appropriate design and validation. The FDA also noted a persistent failure to thoroughly investigate unexplained discrepancies. Specifically, the firm received 80 complaints regarding Fleet Enema container leaks since January 2020 but failed to identify the root cause or implement effective corrective actions, with affected products remaining on the market. Additionally, an inadequate investigation into failed calibration of critical analytical equipment and its impact on tested products was cited. Finally, the inspection highlighted that written procedures for equipment cleaning and maintenance were not consistently followed, leading to numerous overdue preventive maintenance activities despite previous attempts at resolution. C. B. Fleet, Inc. is expected to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure the safety, quality, and efficacy of its drug products and to comply with federal regulations.