FDA 483 - Dextrum Laboratories Inc. - December 16, 2022

Dextrum Laboratories Inc. in Miami, FL, an OTC drug manufacturer, received a Form 483 with 10 observations during an inspection from December 12-16, 2022. The inspection revealed significant deficiencies across multiple areas of Good Manufacturing Practices, including inadequate reprocessing procedures, poorly designed and maintained equipment, contamination risks, lack of cleaning validation, insufficient quality control oversight, and incomplete documentation for manufacturing processes and stability testing. These issues indicate a systemic failure to ensure product quality and safety.