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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…

Failure to Conform to Current Good Manufacturing Practices

In 2001, an inspection of Cardinal Health’s drug manufacturing facility in Winchester, Kentucky showed deviations from “Current Good Manufacturing Practices Regulations” (21 CFR 210, 211), causing certain drug products to be adulterated. The deviations included “batch records [that did not] accurately reflect the actual manufacturing process,” “no documentation that manufacturing employees are trained/instructed following significant changes in procedures” and “failure to have appropriate controls over computerized laboratory systems to assure that changes in or deletions of records are instituted only by authorized personnel.” Cardinal Health was given fifteen working days to complete corrective actions.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
Administrative
Disposition
Administrative Agreement
Date of Inspection Report
7/10/2001
Contractors Involved Penalty
Total
Cardinal Health, Inc. $0
Further Information Released
FDA Warning Letter 8/29/2006

Federal Contractor Misconduct Database