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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended for other attorneys. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-2014

« FDA Answers Ramipril Letters, Explains Why Cobalt Has 180-Day Exclusivity | Main | OBB News Briefs »

February 06, 2008

Comments

Sahil

Breaking News
As a responsible citizen, i want to inform you that Ranbaxy has gone through a very tough inspection at their Dewas plant at India by USFDA .The investigator was a criminal investigator named as Mr Thomas Arista and he gave 28 serious violations of the laws ( 483s)indicating cross contamination issues related to Penicillins to other products apart from many other issues.The inspection started on Jan 28th and ended on 12th Feb .At the end of inspection FDA gave a status of Not Approvable to the plant giving a major blow to Ranbaxy .Paonta Sahib plant of Ranbaxy is already under close scanner for fraudent data due to which no approval has beeen granted to this plant after Jan 2005.You may investigate further and publish the news

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