FDA Warns Novo On Drug Contamination Measures

Law360, New York (February 5, 2013, 2:48 PM EST) -- The U.S. Food and Drug Administration revealed Tuesday that it had sent a warning letter to Danish drugmaker Novo Nordisk A/S, accusing it of failing to properly implement anti-contamination measures at one of its drug manufacturing plants.

According to the letter, dated Dec. 12 but made publicly available Tuesday, a March 2012 inspection of Novo's Bagsvaerd, Denmark-based plant had revealed "significant" violations of the FDA's current good manufacturing practice, including a failure to properly follow procedures designed to prevent microbiological contamination of drug products, and a...
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