FDA 483 - LW Chemicals, Inc. - December 03, 2024

During an inspection conducted from December 2 to December 3, 2024, the FDA issued a Form 483 to LW Chemicals, Inc., an over-the-counter (OTC) human drug manufacturer in Mount Olive, IL. The inspection revealed significant concerns regarding the company's adherence to Good Manufacturing Practices (GMP) for its privately labeled products, such as LW Derma-San ANTI-BAC Hand Soap and Body Shampoo. A primary observation highlighted the absence of an adequate Quality Control Unit, which is essential for providing oversight for distribution activities. LW Chemicals failed to establish written procedures for critical QC functions, including complaint handling, recalls, adverse events, stability testing, and employee training. Furthermore, there were no written quality agreements with their third-party contract manufacturer, nor procedures for qualifying this manufacturer. The company also lacked expiration dating or supporting stability data for distributed products. The FDA also noted insufficient identity and strength testing of drug product components. LW Chemicals, Inc. did not perform adequate testing on products received from its contract manufacturer before distribution, specifically for active ingredients like glycerin, which should include tests for diethylene glycol (DEG) and ethylene glycol (EG). The firm also failed to demonstrate the reliability of its third-party manufacturer's certificates of analysis and lacked written procedures for identity testing. LW Chemicals is expected to implement comprehensive corrective actions to address these serious deficiencies and ensure full compliance with regulatory requirements.