Several months ago, the FDA added two plants operated by Xinxiang Tuoxin Biochemical in Xinxiang City, Henan, China, to its import alert list, and a warning letter posted this week makes clear why. When inspectors looked the facilities over last year, they found buildings full of holes, insects flying in manufacturing areas and equipment in total disrepair.
The short warning letter was sent to the company last month after responses by Tuoxin Biochemical did little to alleviate the FDA’s concerns about manufacturing at the facilities. The agency said the best thing the company could do is bring in outside consultants that can teach it how to meet FDA standards.
The letter said inspectors found non-dedicated drug manufacturing equipment “in a state of disrepair” with reactors that contained significant product buildup and chipped paint. It said the state of the equipment “demonstrates that you have not implemented an adequate preventive maintenance program.” It said that while the company claimed to have a preventive maintenance schedule, it had no records that could prove any of it was ever done.
The buildings were in as bad shape as the equipment, the FDA said, with chipped paint on the ceiling directly above open equipment used for manufacturing, gaps around windows and doors, and holes in ceilings directly above equipment and “lying insects that were observed in clean rooms.”
The FDA warning letter is one in a steady stream in recent weeks for similar problems. The agency recently issued a warning letter to Concept Products, a Tianjin, China-based company that the FDA found lacking in some of the most basic GMP standards. It said the plant had not established procedures for regularly cleaning and maintaining equipment. It also slammed it for never getting a sign-off on products from its quality control people before releasing products and failed to do stability testing to determine how the active pharmaceutical ingredients (APIs) should be stored and their appropriate expiration dates.
The findings come as China now has 50% of the global API market. and exports of pharma products from Chinese companies to the U.S. grew 4% last year.
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