Mexico’s Glicerinas Industriales, which supplies drug components like glycerin to pharmaceutical manufacturers, was nailed with an FDA warning letter that cited the company for product testing and documentation issues.
The warning letter (PDF), dated Jan. 16, follows an inspection conducted at the company's Zapopan facility from May 8 to May 12 last year. It also comes in the wake of a separate warning letter from June 2022, when the FDA put the company on notice for refusing an inspection.
In the latest warning, Glicerinas Industriales (which also goes by the name Glinsa) was chastised for failing to test batches of incoming production material and not “appropriately” qualifying suppliers. The agency also dinged the company for not documenting and investigating any deviations from established procedures.
“You failed to conduct adequate identity testing to monitor for the risk of DEG (diethylene glycol) or EG (ethylene glycol) contamination,” the FDA said. “The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. “
The company had previously been warned by the regulatory agency for not meeting good manufacturing requirements for testing of high-risk drug components like glycerin, according to the FDA.
The FDA further slammed Glinsa for not investigating deviations from its quality specifications for repackaged drugs. The agency said the company didn’t follow up on the presence of particulates in “numerous” packaged products.
Previously, during a phone call with the FDA’s Office of Regulatory Affairs in February 2022, Glinsa refused a pre-announced inspection. The following month, the company again snubbed the FDA inspection after receiving a written notification.
Those interactions were at the center of a prior reprimand from the U.S. drug regulatory.
As a result of the latest warning letter, Glinsa was placed on an import alert last week. Under such an alert, all future shipments of products made at the company’s facility may be refused entry into the U.S. unless the company can show the facility is in compliance with manufacturing standards.