South Korean drugmaker Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
In the letter posted on the agency’s website earlier this week, the FDA said Dasan failed to adequately test raw materials and finished products to verify they conformed to appropriate specifications.
The agency noted the company failed to analyze glycerin raw material from one of its suppliers before using it in drug product manufacturing. The company did not test to see if diethylene glycol (DEG) or ethylene glycol (EG) was present.
“DEG contamination in pharmaceuticals has resulted in various lethal poisoning incidences in humans worldwide," the agency said, noting its 2007 guidance on DEG testing.
The FDA said Dasan had “poor control” over its manufacturing processes and that it failed to establish scientifically sound laboratory controls. It also lacked adequate written procedures for production and process control, and the company was unable to show that its microbial limits tests method was fit to detect microorganisms in the presence of its products.
Additionally, the FDA said the company released certain products, including a lot of one of its creams, "without testing each active ingredient for identity and strength."
The inspection took place Jan. 23-26.