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# Mexican Firm Refuses FDA Inspection
- URL: https://www.fdaweb.com/mexican-firm-refuses-fda-inspection/
- Published: 2022-06-21T12:00:00.000Z
- Updated: 2026-09-14T17:49:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152106

FDA says Glicerinas Industriales, a Zapopan, Mexico, drug manufacturing facility, was advised of a planned agency inspection on 5/16-5/20 and refused to allow the inspection. A 6/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glicerinas-industriales-sa-de-cv-633340-06132022?ref=fdaweb.com) says the firm supplies drug components such as glycerin to manufacturers of finished drug products that are distributed in the U.S. It notes that the use of glycerin contaminated with diethylene glycol has resulted in various lethal poisoning incidents in humans worldwide.

The letter says the firm’s drugs are legally considered to be adulterated since they were produced in a facility that refused an FDA inspection. The company was placed on an Import Alert on 6/9.

Glicerinas was told to respond with any additional information it wants the agency to consider as it assesses the company’s activities and practices or to respond with a request to schedule an inspection.