Earlier this month, the FDA banned all products being shipped to the US by a Chinese API maker. 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 the 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, even though 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 the time the inspectors got there. 

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 will 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 US 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, 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.