Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

You may also be interested in...

FDA Seizure Of Paxil CR, Avandamet Follows GSK's Failure To Recall All Lots

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.

Italy Leads European Push Into Conditional Reimbursement

Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts