In January 2013, FDA inspectors made public a warning letter issued to a Taiwanese chemical manufacturer in December. Citing serious violations of recordkeeping and in-process testing, the letter said that Beanne Chemical facility had failed on multiple counts to validate its manufacturing process. For example, the company — which makes cosmetics and health food products for export — provided no raw data to back up reported counts of arsenic, lead, mercury and E. coli in their finished lots. Federal regulators are still waiting on Beanne’s response.
The Beanne case highlights a growing problem for the FDA: an explosion in the number of foreign plants that export to the U.S. market. The FDA must now track more foreign than domestic manufacturers, and they often lack the manpower, funding and local expertise to do the job right.
This is especially true in China, where thousands of plants produce bulk APIs for U.S. and Western drug companies. Before 2007, the FDA had no offices or regulators in China. They now have facilities in three cities and an inspection team of 13. But that is a small force compared to the size of the challenge they face.
When it comes to inspections, simply accessing foreign facilities can be difficult. The FDA has no power to force overseas manufacturers to allow inspections. When they do discover violations, they cannot take punitive actions, except to turn away products at the U.S. border. FDA China Director Christopher Hickey said in a 2011 Wall Street Journal article that an estimated one-third to one-half of all drug makers in China operated in violation of good manufacturing practices.
With new funding from fees on generic drugmakers, the FDA plans to increase its foreign inspections. To do so effectively, the agency is constantly seeking ways to cooperate with local regulators. In addition to its offices in China, the FDA has Asia-based staff stationed permanently in New Delhi and Mumbai, India.