FDA 483 - C. B. Fleet Company, Inc. - April 18, 2025

C. B. Fleet Company, Inc. in Lynchburg, VA, was inspected and cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products. The inspection revealed a systemic failure to thoroughly investigate consumer complaints and out-of-specification results related to microbiological contamination, as well as inadequate laboratory controls and a lack of established test method specificity. Furthermore, the Quality Unit failed to implement proper risk assessments for objectionable microorganisms and ensure the effectiveness of its sanitation program.