A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.
The FDA posted a warning letter this week for Huaian Zongheng Bio-Tech for its plant in Huaian, China, which it says makes over-the-counter drug products, many of them for children. It says the company ships them to the U.S. without testing ingredients or retained samples of the finished products to see if they meet specs.
The company’s products were also put import alert in November.
The FDA was particularly concerned over the fact that the company uses glycerin in some of its products, pointing out that the use of “glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents in humans worldwide.”
The company was ordered to rely on FDA guidance for use of the ingredient.
The FDA was concerned enough about the products of Huaian Zongheng Bio-Tech that it recommended it get a third-party consultant to help it meet FDA manufacturing standards.
China and India account for more FDA warning letters than any other countries. Chinese OTC products are sold through many retailers in the U.S. In fact, the FDA in November issued a warning letter to the parent of the Dollar Tree and Family Dollar stores because the company was buying many of its OTC products from Chinese companies that were among the worst offenders, including some whose products had been banned in the U.S.