X hits on this document

65 views

0 shares

0 downloads

0 comments

17 / 35

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.

17

Document info
Document views65
Page views64
Page last viewedSat Dec 03 02:48:07 UTC 2016
Pages35
Paragraphs407
Words3160

Comments