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FDA is using GMP Warning Letters to raise other compliance issues

  • Several of the past year’s GMP Warning Letters incorporated other compliance issues, including allegations of:

    • Unapproved new drugs

    • Misbranded drugs

    • Promotional issues

  • Pharmacy compounding

  • These letters suggest that the FDA is taking a more holistic

approach to enforcement when it identifies violative conduct

  • FDA may also start taking a closer look at pharmacovigilance

systems during future GMP inspections

© 2009 Hogan & Hartson LLP. All rights reserved.

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