FDA 483 - RWM Technologies LLC - December 12, 2025

BWN Technologies LLC in Chattanooga, TN, was inspected and cited for significant deficiencies across its quality control unit, facility maintenance, and testing programs for both human and animal OTC drug products. Key issues include inadequate quality unit procedures, poor facility conditions, insufficient raw material and finished product testing, and a failure to follow stability testing protocols. These observations indicate a broad lack of adherence to current good manufacturing practices.