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

An FDA inspection of Dextrum Laboratories Inc., an OTC liquid drug product manufacturer in Miami, revealed significant deficiencies in their quality systems and manufacturing processes. Observations included failures in maintaining a validated water system, inadequate component testing for high-risk materials, and a lack of proper stability testing facilities. The firm also demonstrated widespread issues with documentation, quality control unit procedures, incomplete process validations, and insufficient measures to prevent microbiological contamination.