Chinese Manufacturer Cited for Failing to Disclose Information to FDA, Maintain GMP Standards in Warning Letter

The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards.

During a June inspection of the company’s Jiangsu facility, FDA investigators asked the company’s management to disclose the details of its microbiological testing processes, but the company official balked, saying he would not disclose trade secrets.

Additionally, the FDA cited the facility for not maintaining sanitary conditions. Investigators observed a black, mold-like material on the floors and walls, water on the floor and live insects at the entrance of a storage area for the company’s drugs.