China-based Huaian Zonghen Bio-Tech, an OTC drugmaker, has been issued the first FDA warning letter of the year for multiple CGMP violations.
Much of the violations cited by the agency related to the company’s testing of its OTC products, many of which are marketed to children. In particular, the agency said that Huaian failed to adequately determine the strength and identity of active ingredients, or establish an adequate written program for stability testing.
The FDA pointed to Huaian’s use of glycerin as a source of concern given that glycerin contaminated with diethylene glycol has proved to be lethal in humans in the past. The agency recommended that the company follow FDA guidelines for manufacturing products with that ingredient.
The FDA also said that Huaian failed to use the appropriate manufacturing equipment for its drug products, provide evidence that its maintenance meets microbial standards or conduct needed risk assessments of its equipment.
Read the FDA warning letter.
