Glicerinas Industriales, S.A. de C.V.

Warning LetterOpen

Mr. Carlos Andres Gomez Rodriguez General Director Glicerinas Industriales, S.A. de C.V. Calle Uranio No. 80 Col. Arenales Tapatios 45066 Zapopan , Jal. MexicoFEI 3016420687Issued Jan 16, 2024Center for Drug Evaluation and Research | CDER

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Violations1

Issue DateJan 16, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Glicerinas Industriales, S.A. de C.V.
Location: Mr. Carlos Andres Gomez Rodriguez General Director Glicerinas Industriales, S.A. de C.V. Calle Uranio No. 80 Col. Arenales Tapatios 45066 Zapopan , Jal. Mexico
FEI Number: 3016420687
Country: Mexico
Issue Date: January 16, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

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.

Glicerinas Industriales, S.A. de C.V. FDA Warning Letter, January 16, 2024