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Article: West Agro assay methods do not conform to USP specs.(Brief Article)
- Article from:
- Validation Times
- Article date:
- May 1, 2002
CopyrightCOPYRIGHT 2002 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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A Feb 12-15, 20 and 25 inspection of iodide manufacturer West Agro revealed the firm's laboratory control sheets listed multiple assay methods without noting the actual method used for the specific analysis, inadequately validated assay methods and product specifications which do not conform to U.S. Pharmacoepia (USP) specifications.
However, the audit of the firm's Kansas City, MO, facility remained incomplete as unnamed investigators were denied access to certain parts of the plant, according to the March 28 warning letter.
Kansas City District District Director Charles Sedgwick blasted the firm in the letter for its refusal to allow investigators ...
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Article: Construction, Sanitation & Maintenance (A-W). (Product Guide).
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700+ words
... ... Controls Corp. K-Klean, A Division of West Agro, Inc. Nelson-Jameson, Inc. Unitherm ... Hantover Direct K-Klean, A Division of West Agro, Inc. Mandeville Co., Inc. Nelson ... Process Systems K-Klean, A Division of West Agro, Inc. Lechler, Inc. LeFiell Company ...
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