GlaxoSmithKline (GSK) agreed to pay $40.75 million to settle allegations it was manufacturing substandard prescription medications in the early 2000s.
GSK was alleged to have involved in production of substandard products, made from 2001 through 2005 at its former manufacturing facility in Cidra, Puerto Rico. Those included the antidepressant Paxil CR, the anti-infection ointment Bactroban, the sterile anti-nausea medication Kytril, and the type-two diabetes pill Avandamet.(WCxKit)
The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement. According to information from the company, which has offices in the U.S. and Great Britain, GSK chose to settle the matter to avoid the expense and uncertainty of protracted litigation and trial.
In 2009, GSK closed the plant because of declining demand for the medicines made there. GSK sold the facility in 2010. Prior to selling the facility, the company reportedly brought the plant into compliance and to a level of performance that satisfied both GSK and the FDA.
According to the company, GSK’s manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies – including the FDA – conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries.(WCxKit)
The FDA has raised no material issues as a result of its other inspections, according to GSK. The fine will be divided among 37 states and the District of Columbia as part of the agreement.
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