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FDA is focusing more on import compliance and is leveraging DOJ resources

Ranbaxy situation

  • After FDA re-inspected Ranbaxy for cGMP violations, DOJ subpoenaed Parexel & Co., a consulting firm that Ranbaxy’s attorneys hired, and moved to compel, over attorney’s privilege claims

  • FDA told Ranbaxy that it would not act on Ranbaxy’s applications unless it received the consultant’s audit reports

  • Demonstrates greater leveraging of DOJ resources in traditional FDA cGMP matter

  • Demonstrates more aggressive position regarding attorney-client and work product privileges

  • Reflects greater concern about API manufactured abroad

© 2009 Hogan & Hartson LLP. All rights reserved.

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