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Nearly all recent GMP Warning Letters cite the inadequacies of the response

  • In the past 12 months, FDA has issued more than 20 pharmaceutical GMP Warning Letters

  • Virtually all of those letters address the inadequacies of the company’s response to inspectional observations

  • This is a good reminder of why its necessary to submit a high quality response demonstrating the company’s commitment to implementing aggressive corrective action to address inspection observations

Good Responses to a 483 Observation

  • Problem fixed

  • Problem will be fixed by [Fill in Date]

Bad Responses to a 483 Observation

  • FDA is wrong

  • The observation is trivial

  • The inspectors didn’t understand our science

  • The inspectors misinterpreted the law

© 2009 Hogan & Hartson LLP. All rights reserved.

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