FDA 483 - The Original Bradford Soap Works, Inc. - May 27, 2025

The FDA inspected The Original Bradford Soap Works, Inc. in West Warwick, RI, a manufacturer of Over the Counter (OTC) drug products. The inspection revealed significant deficiencies in documentation practices, including failures to verify component weights and line cleaning at the time of performance. Additionally, the firm's equipment cleaning validation studies were found to be deficient, lacking microbial bioburden testing and proper risk assessments, with one issue being a repeat observation.