FDA 483 - Dextrum Laboratories Inc. - July 18, 2023

Dextrum Laboratories Inc., an OTC drug manufacturer in Miami, FL, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of validated manufacturing processes and water system re-validation, incomplete and non-contemporaneous master production records, and inadequate annual product review procedures. Additionally, the firm failed to verify component supplier analyses and lacked proper ventilation and containment systems for active pharmaceutical ingredients and organic solvents.