GSK Reaches Consent Decree With FDA Over cGMP Issues at Puerto Rico Plant

GlaxoSmithKline (GSK) expects to begin resupplying the U.S. and foreign markets with Paxil CR and Avandamet by midyear after reaching a consent decree agreement with the FDA regarding manufacturing violations at its Cidra, Puerto Rico, plant.

The FDA halted production of antidepressant Paxil CR (paroxetine HCl, controlled release) and diabetes drug Avandamet (rosiglitazone maleate/metformin HCl) in early March because of ongoing concerns about manufacturing problems at the Cidra facility, where the products have been made since 2002.

Before it can restart the plant, GSK must meet all the requirements contained in the consent decree -- a goal the company said it hopes to meet within 90 days following the entry of the decree. The agreement calls for an independent expert to review the Cidra facility's manufacturing processes to ensure the plant meets current good manufacturing practice requirements. GSK must also provide the FDA with a report on any deficiencies identified by the reviewer and submit a corrective plan to address those problems.

GSK said it believes it has identified the source of the manufacturing issues related to both drugs, and has already implemented corrections to address the problems. The company is now validating those changes through a third party.