FDA warns Mexican glycerin manufacturer for refusing an inspection
A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.
According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.
The company, which also goes by Glinsa, is a supplier of a wide range of drug ingredients, including glycerin, to manufacturers of finished drug products. These include manufacturers that distribute to the US. The letter made clear the importance of the inspection given that the use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents over the years in various countries.
According to the FDA’s guidance on the subject from 2007, that regulator has received and continues to receive reports about fatal DEG poisoning of consumers who ingested medicinal syrups, such as cough syrup, that were manufactured with DEG-contaminated glycerin.
According to the letter, the company’s drugs are now “adulterated” in that they have been manufactured, processed, packed or held in an establishment that delays, denies or limits an inspection, or refuses to permit entry or inspection.
The FDA placed the company on Import Alert on June 9, and until the FDA is permitted to inspect the facility and enters compliance, they can withhold approval of any new applications or supplements listing it as a drug manufacturer. In addition, shipments of articles manufactured at Glicerinas Industriales into the US that appear to be adulterated are subject to being detained or refused admission.
In 1937, an outbreak of DEG poisoning occurred in the US, which resulted from people ingesting an elixir of sulfanilamide that contained DEG as a solvent, resulting in 107 deaths, many of them children, which in part led to the Food Drug & Cosmetics Act to be passed. In late 1995 and early 1996, many children were admitted to hospitals in Port-au-Prince, Haiti, with sudden kidney failure, resulting in at least 80 fatalities, following similar poisoning.