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  • FDA: China Still Withholding Promised Visas Meant to Bolster Inspectional Capacity

    Late last year, US officials announced what they said was a breakthrough for the US Food and Drug Administration's (FDA) efforts to ramp up its inspection presence in China-a region with increasing pharmaceutical exports to the US. Background Under the terms of the December 2013 agreement between White House and Chinese officials, China was set to allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House...
  • As White House Announces Breakthrough for FDA in China, Could Warning Letters Increase?

    If you follow the US Food and Drug Administration's (FDA) Warning Letters with any regularity, you know that the agency has been keeping a tight eye on Indian pharmaceutical manufacturers. But under the terms of a recent agreement, Chinese companies might soon find themselves in similar circumstances. Background FDA has long been hamstrung in its ability to inspect foreign manufacturers of pharmaceutical products, and in particular generic pharmaceuticals and active pha...
  • Chinese Firm Threw FDA Inspectors out Mid-Inspection, Agency Says

    The US Food and Drug Administration (FDA) regularly inspects thousands of manufacturing facilities around the globe. What isn't so regular is the owners of one of those facilities throwing FDA inspectors in the middle of an inspection and in the midst of allegations of serious manufacturing problems. According to FDA, the agency had arranged to inspect Fercy Personal Care Products' Jinhua, China-based manufacturing facility between 5 March and 9 March. The inspection sta...