Most pharmaceutical companies probably aren’t thrilled by the prospect of an FDA manufacturing inspection, but simply ignoring the issue doesn’t make it go away. Now, one drugmaker is learning that lesson the hard way after it rebuffed U.S. regulators earlier this year.
Mexico’s Glicerinas Industriales, which supplies drug components like glycerin to manufacturers making finished meds for the U.S., has been slapped with an FDA warning letter—not over production deficiencies but because the company refused an inspection outright, FDA said this week.
The agency previously told Glicerinas Industriales, which also goes by the name Glinsa, that it planned to inspect the company’s drug manufacturing facility in the Mexican city of Zapopan from May 16 to May 20. Problem is, Glinsa in February “refused the pre-announced inspection” on a phone call with representatives from the FDA’s Office of Regulatory Affairs, the agency said in its warning letter.
Glinsa also rebuffed the FDA inspection after receiving written notification on March 23, the FDA added.
Drugs made with glycerin tainted with diethylene glycol (DEG) have spurred “various lethal poisoning incidents in humans worldwide,” the FDA warned. Back in 2007, the agency published guidance alerting drugmakers, compounders, repackers and suppliers of the issue. The FDA also laid out testing recommendations to help companies avoid the use of DEG-contaminated glycerin and prevent cases of DEG poisoning.
FDA cited its glycerin guidance document in its letter to Glinsa.
And because Glinsa refused FDA’s inspection, the company’s drugs are now classified as “adulterated,” the regulator said. Further, FDA says it placed Glinsa on its import alert list on June 9.
Until the agency is allowed to inspect Glinsa’s plant and confirm that its manufacturing operations are up to par, the FDA says it may withhold approval of any new applications or supplements where Glinsa is listed as a drug manufacturer. Further, U.S. shipments from Glinsa’s Zapopan facility that appear to be adulterated are “subject to being detained or refused admission,” the FDA added.
Glinsa has 15 days from June 13 to respond to the FDA’s complaint, the warning letter states.