The FDA issued a warning letter to a Chinese drugmaker for significant cGMP violations related to identity testing, process validation and its written stability program.
An inspection of Hangzhou Badi Daily Use Chemical’s Huzhou, Zhejiang facility revealed a lack of testing for identity, purity, strength and other quality attributes. The firm admitted that it did not conduct such tests on components, including an API, used in certain OTC drug products, and had no records of receiving the labeled active ingredient.
The FDA flagged the violation as particularly serious because the firm makes drug products containing glycerin. Each lot of glycerin needed to be analyzed for the presence of two contaminants, diethylene glycol (DEG) and ethylene glycol (EG), as drugs contaminated with DEG have been responsible for lethal poisoning incidents, the agency said.