FDA 483 - Dextrum Laboratories Inc. - August 29, 2024
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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.
ID · 5fefa31f-4e30-423d-8aef-04db7c079282