Loading…
Glicerinas Industriales, S.A. de C.V., a Mexican drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) requirements for active pharmaceutical ingredients (APIs) and excipients, resulting in adulterated products. The company did not adequately test incoming materials for identity or properly qualify suppliers, particularly failing to monitor glycerin and other high-risk components for contamination with diethylene glycol (DEG) or ethylene glycol (EG)—contaminants that have caused lethal poisoning incidents globally. These deficiencies in ingredient verification and supplier controls posed a direct safety risk to finished pharmaceutical manufacturers and end users who relied on the company's repackaged drugs as components in their products.