Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSuhan Aerosol, an Indian OTC drug manufacturer, failed to comply with current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products—including children's toothpaste and hand sanitizer—adulterated. The company's primary violation was the failure to conduct identity testing on high-risk incoming components (glycerin, propylene glycol, and sorbitol solution) to verify they were not contaminated with diethylene glycol (DEG) or ethylene glycol (EG), as required by 21 CFR 211.84(d)(1). The FDA issued this warning based on records submitted in response to a January 2023 information request.