OTC Gel Manufacturer Cited for Ingredient Testing, Process Validation Failures

The FDA hit OTC oral gel manufacturer Europharma Concepts with a warning letter after finding significant CGMP violations at its facility in Ireland.

In a November inspection, the agency found that the company failed to test certain lots of glycerin used in its gel for the presence of diethylene glycol (DEG) and ethylene glycol (EG) prior to releasing the product.

DEG-contaminated glycerin has led to several lethal poisoning incidents, the FDA noted.