GSK completes previously reported settlement with U.S. Department of Justice regarding former manufacturing plant
Issued: Tuesday, 26 October 2010, Research Triangle Park, NC and London UK
GlaxoSmithKline today announced that it has finalized a previously reported agreement in principle with the U.S. Attorney's Office for the District of Massachusetts and the U.S. Department of Justice (DOJ) with respect to the investigation of the company's former manufacturing facility in Cidra, Puerto Rico.
GSK disclosed a $750 million (£500 million) charge to its second-quarter 2010 earnings on July 15 in connection with the agreement in principle. No additional charge to the company's earnings will be recorded in connection with the settlement.
"This settlement resolves a significant and long-standing legal issue facing the company," said PD Villarreal, GSK's Senior Vice President and Head of Global Litigation. "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes. Our commitment to compliance with cGMP is demonstrated by the fact that we have not received an FDA warning letter at any plant since the Cidra facility was cited in July 2002."
This settlement resolves issues at one manufacturing facility that took place over five years ago. The plant in Cidra, Puerto Rico, was closed in 2009 due to declining demand for the medicines made there. GSK no longer owns the facility.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.