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FDA warns 8 manufacturers for failing to register plants

By Nick Taylor , 07-Jun-2012
Last updated on 07-Jun-2012 at 11:12 GMT

The US FDA has sent warning letters to eight biopharma companies for failing to register production facilities.

In each of the warning letters, six of which were sent to firms in Asia-Pacific, the US Food and Drug Administration (FDA) criticises companies for importing drugs into the US without registering plants.

Our records indicate that you have not registered your establishment within 2011 or 2012, but have continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the US”, the FDA wrote in each of the warning letters.

In recent years the FDA has received criticism, notably from the US Government Accountability Office (GAO), for shortcomings in its database of overseas manufacturing facilities. Sending the letters, all of which went to overseas companies, signals a push to tighten up oversight of the global supply chain.

FDA efforts to strengthen its control of the supply chain will receive a boost when it starts getting fees for inspection fees from generics firms. In its goals for the Generic Drug User Fee Act (GDUFA) the FDA said it wants build new drug production facility databases or improve existing assets.

Global clampdown

The FDA sent three of the warning letters to companies in China, including one based in Hong Kong, and another two to Indian firms. Companies in France, Colombia, and South Korea received the three remaining warning letters.

Each company was warned of the need to register by the FDA last year in either August or October but has failed to act on the recommendation. In response the FDA has sent each a warning letter and said customs may refuse imports until the companies register their facilities online.

The firms cited in the warning letters are:

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