FDA Warns CR Bard Over 'Adulterated' Med. Devices

Law360 (October 14, 2008, 12:00 AM EDT) -- A U.S. Food and Drug Administration inspection of a Puerto Rico plant of medical device maker C.R. Bard Inc. revealed a slew of manufacturing problems, the agency revealed in a letter made public Tuesday.

FDA inspectors who visited the company's plant in Humacao, Puerto Rico, between November 2007 and February 2008 found that gastroenterological, cardiovascular and surgical medical devices manufactured there were “adulterated,” according to the letter, which was sent in July.

Manufacturing and storing methods at the plant were not in conformity with the Current...
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