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FDA Cites GSK Puerto Rico Manufacturing Facility In "483" Report

This article was originally published in The Pink Sheet Daily

Executive Summary

Following a November 2004 inspection, FDA issues GlaxoSmithKline a "Form 483" report for its facility in Cidra, Puerto Rico. The manufacturing plant produces Paxil, Avandia and Coreg. GSK is recalling one lot of 10 mg Paxil tablets manufactured at the Puerto Rico plant; the recall is not related to the 483, the company says.

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