FDA Cites GSK Puerto Rico Manufacturing Facility In "483" Report
This article was originally published in The Pink Sheet Daily
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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GlaxoSmithKline's February recall involving the two drugs did not encompass all affected lots, FDA says in announcing seizure of all doses and lots of the products. The action follows two "Form 483" reports in the last two years for GSK's Cidra, Puerto Rico facility, where the antidepressant and antidiabetic drugs are manufactured.
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