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Latest From International Isotopes Inc.

FDA Sending More Drug GMP Warning Letters to Foreign Sites

FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.

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  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Pharmaceuticals
    • Radiopharmaceuticals, Contrast Agents
  • Medical Devices
    • Implantable Devices
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