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Federal Contractor Misconduct Database (FCMD)

The federal government routinely awards contracts to companies with histories of misconduct, including contract fraud and other violations. POGO believes that providing this website will help to improve contracting decisions and increase public knowledge of how the government spends billions of taxpayer dollars each year. Read more…

Puerto Rico Drug Manufacturing Facility Settlement

SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, agreed to plead guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution included a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act for $600 million. The drugs, manufactured at the plant between 2001and 2005, included Kytril, Bactroban, Paxil CR and Avandamet. The government alleged that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban were free of microorganism contaminants; that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split, causing the potential distribution of tablets that did not have any therapeutic effect; that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients; and that SB Pharmco’s facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.

Misconduct Type
Health
Enforcement Agency
Multiple Agencies
Contracting Party
None
Court Type
Criminal
Disposition
Pleaded Guilty
Date of Settlement Announcement
10/26/2010
Contractors Involved Penalty
Total
GlaxoSmithKline $750,000,000
Further Information Released
Complaint 11/4/2010
DOJ Press Release 11/4/2010
DOJ Settlement Conference Remarks 11/4/2010

See also:

Federal Contractor Misconduct Database