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Re: U.S. v/s Barr Laboratories


   While I wasn't the questioner, I want to thank those giving the GMP1st website as containing the link to the entire US v. Barr decision. I've been searching for quite a while.

  However, one must be aware that the decision rendered by Judge Wolin on Feb. 5, 1993 which is linked to this website, was amended on March 30th, 1993. The amended version is the final version and should be viewed for the sake of completeness. I briefly compared the amended to the unamended decisions and found some minor differences especially in the later sections concerning Cleaning Validation, Record-Keeping deficiencies, ANDA-related discussion and small changes in the conclusion and footnotes (there very well may be others). The changes do not alter the general conclusions of the decision in any substantive way (although I could have missed something). But it should be read just as the most updated version of any regulatory document should be read since this decision is considered a "defining moment"  in the history of cGMP legal interpretation. I would appreciate obtaining a link to the amended decision of March 30, 1993 if there is one lurking somewhere on the web.&nb

    Bob K..

R. B. Kirsch Consulting
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Arlington Heights, IL  60004
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