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

Warning LetterOpen

Mr. Alfredo Moran Sanchez Director Glicerinas Industriales, S.A. de C.V. Calle Uranio No. 80 Col. Arenales Tapatios 45188 Zapopan , Jal. MexicoFEI 3016420687Issued Jun 13, 2022Center for Drug Evaluation and Research | CDER

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Violations0

Issue DateJun 13, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Glicerinas Industriales, S.A. de C.V.
Location: Mr. Alfredo Moran Sanchez Director Glicerinas Industriales, S.A. de C.V. Calle Uranio No. 80 Col. Arenales Tapatios 45188 Zapopan , Jal. Mexico
FEI Number: 3016420687
Country: Mexico
Issue Date: June 13, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Glicerinas Industriales, S.A. de C.V., a Mexican manufacturer of drug components including glycerin, refused FDA's pre-announced inspection of its facility in February and March 2022, resulting in a determination that its drugs were adulterated under section 501(j) of the FD&C Act. The company's refusal to permit inspection was particularly significant given the known risks of glycerin contamination with diethylene glycol (DEG), which has caused lethal poisoning incidents worldwide. FDA placed the firm on Import Alert 66-79 on June 9, 2022, and stated it would withhold approval of any new drug applications or supplements listing the company as a manufacturer until the facility could be inspected and CGMP compliance confirmed.

Glicerinas Industriales, S.A. de C.V. FDA Warning Letter, June 13, 2022