Earlier this month, the FDA banned all products being shipped to the U.S. by a Chinese API maker, and a new warning letter explains why. It appears the ingredient maker had no clue, or didn't care, about how to meet basic FDA GMP expectations.
The warning letter for Changzhou Jintan Qianyao Raw Material Factory followed an inspection of its plant in Jintan district of Changzhou, Jiangsu Province, in February. The FDA said it found that before August 2016, the company did not have any quality-related procedures in place, despite the fact that it was manufacturing and shipping drugs to the U.S. The management had drafted a few procedures ahead of the inspection in February but still hadn’t implemented any of them by time the inspectors got there.
For example, when investigators asked for a list of critical raw materials and the plant’s sampling requirements, they were told there were no written procedures for testing and sampling incoming materials. Instead, warehouse employees accounted for incoming raw material handling, sampling, and testing “in their heads.”
The batch testing that was performed was done over and over again, and only some of the results were recorded. The FDA suggested that if the company intends to continue to do business in the U.S. that it hire a consultant that can help it establish all of the processes and controls needed to meet FDA standards.
The FDA added the plant to its import alert list on May 4.
The FDA has stepped up its inspections of Chinese companies, which produce many of the APIs that end up in drugs produced in and for the U.S. market. The results have indicated that many Chinese companies have a long way to go to meet FDA standards.
A review of the 42 warning letters issued by the FDA’s Office of Manufacturing Quality in 2016 showed that a third of them them, 14, were issued to Chinese companies. While many of the Chinese companies hit with FDA citations are small, some of the industry’s biggest drugmakers have also had issues with their plants in China.
Just last month, the FDA posted a warning letter for a Teva API plant in Xiaoshan, Hangzhou, in Zhejiang. The FDA said that for nearly two years the Teva facility struggled with impurity issues, problems that affected about 20% of production. Teva has said it is working to resolve the problems.