FDA 483 - Dextrum Laboratories Inc. - August 29, 2024

During an inspection conducted from August 19 to August 29, 2024, Dextrum Laboratories Inc., an OTC liquid drug product manufacturer based in Miami, FL, received an FDA Form 483 detailing significant observations of objectionable conditions. The inspection revealed critical deficiencies across the company's quality and production systems, indicating non-adherence to regulatory expectations for drug product manufacturing under Current Good Manufacturing Practices.

Key violations included a failure to maintain the validated water system under control, evidenced by numerous out-of-specification results for Total Organic Carbon (TOC), and the release of products, such as Giltuss Honey DM, manufactured during these non-compliant periods. The company also failed to complete essential testing for high-risk raw materials, specifically for Diethylene Glycol (DEG) and Ethylene Glycol (EG), on numerous retained samples dating back to January 2023.

Further issues comprised an inadequate stability testing program, lacking a properly controlled chamber, and widespread failures within the quality control unit to implement and follow written documentation procedures. This included missing logs for finished product shipments, undocumented cleaning processes for major equipment and production rooms, and incomplete laboratory record entries. Additionally, the firm had incomplete process validations for various formulations and lacked established procedures to prevent microbiological contamination during raw material weighing. Dextrum Laboratories Inc. is required to provide a comprehensive response outlining corrective actions to address these serious findings.