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Key Takeaways: GMP Enforcement

  • FDA is now putting more focus on international suppliers, and soon will have even more inspection resources

  • Companies need to re-examine their relationships with third party product and service suppliers

    • Companies must have a rigorous GMP audit program for their suppliers

  • More than ever, companies need to ensure that their 483 responses directly address all of FDA’s concerns and provide firm commitments to rigorous corrective action

  • The agency may use GMP inspections and Warning Letters to raise other compliance violations

  • FDA is closely scrutinizing the effectiveness of Quality Control Units

© 2009 Hogan & Hartson LLP. All rights reserved.

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