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Article: Revalidation, microbe tests snare Geneva Labs.(Brief Article)
- Article from:
- Validation Times
- Article date:
- September 1, 2000
CopyrightCOPYRIGHT 2000 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Annual revalidations and microbial tests for sterile products led FDA concerns in an inspection of contract testing lab Geneva Labs of Elkhorn, WI, but Minneapolis district inspector Charles Cote really had little to grouse about.
The seven-page EIR (the 483 was not released) documented a March 1999 audit in which the firm won a recommendation for approval by the district.
Cote wrote that Geneva performed its microbial tests per the USP standard and that the firm "validates each test article to ensure that it neither suppresses growth [n]or encourages false positive results." According to the EIR, the firm conducted annual revalidations for projects ...
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Article: Geneva Steel to install $95 million continuous casting ...
PR Newswire;
October 22, 1990 ;
700+ words
...GENEVA STEEL TO INSTALL $95 MILLION CONTINUOUS ... of its announced modernization program, Geneva Steel (NYSE: GNV) said today that it ... slabs. The facility will be connected to Geneva's existing rolling mill operation to allow ...
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