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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…

Current Good Manufacturing Practice Violations at Worthing, UK Facility

The U.S. Food and Drug Administration (FDA) issued a warning letter to SmithKline Beecham Limited that it had violated Current Good Manufacturing Practice (CGMP) regulations at its manufacturing facility in Worthing West Sussex, United Kingdom. The FDA found that the company did not establish appropriate written procedures designed to prevent microbiological contamination of drug products purported to be sterile, failed to follow laboratory control procedures, and that the quality control unit did not adequately exercise its responsibilities to approve procedures or specifications that may impact the identity, strength, quality, and purity of the drug product.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
N/A
Disposition
Investigative Finding
Date of Warning Letter
10/7/2011
Contractors Involved Penalty
Total
GlaxoSmithKline $0
Further Information Released
FDA Warning Letter 10/21/2011

Federal Contractor Misconduct Database