FDA finds fault with Chinese API maker

Tianjin Zhongan Pharmaceutical announced in 2010 that it had passed its first FDA inspection with flying colors, no 483 observations. Its most recent inspection didn't go as well. On Tuesday, the FDA posted a warning letter sent last week to the Chinese ingredient maker listing problems with keeping equipment clean and running down problems.

The letter is tied to an inspection done in September 2013 at its plant in Tianjin. Inspectors first noted that the company was not adequately cleaning equipment and that they had found "various levels of contamination and foreign objects inside" some unidentified units. The agency also chastised the company because employees documented that the equipment had been cleaned when it clearly had not, the warning letter says.

Further, the company had not documented changes it had made to processes. Inspectors knew because the company was using different equipment to manufacture some active pharmaceutical ingredients (APIs) than a filed flowchart indicated. And finally, the company didn't bother to investigate the source of particulate, including plastic that appeared to come from a pen that was found in at least one batch.

The FDA has been devoting more attention to manufacturers in China, a country that accounts for many of the APIs imported into the U.S. but one with limited oversight by its own regulatory agencies. The agency is in the process of hiring and stationing in the country 10 new drug inspectors to pick up the pace of oversight there, a process that has been impeded by the government sitting on visas for new inspectors. China agreed last year to let them in, but as of April there were only two, according to testimony by Christopher Hickey, director of the FDA's China office, to the U.S.-China Economic and Security Review Commission. That fact elicited from one committee member the observation that it appeared the FDA was "woefully, inadequately staffed for this job."

- here's the warning letter