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Talk to a SpecialistTalk to a SpecialistNeilMed Pharmaceuticals Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs, rendering their products adulterated. The company failed to conduct identity testing on incoming components—specifically glycerin and other high-risk materials—to verify they met safety standards and detect hazardous impurities like diethylene glycol (DEG) and ethylene glycol (EG) as required by USP standards. The firm also failed to validate and establish the reliability of component supplier test analyses at appropriate intervals, instead improperly relying on unqualified suppliers' certificates of analysis. These violations were identified during an FDA inspection conducted November 28 to December 2, 2022, at the company's Santa Rosa, California facility.