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About POGO's Federal Contractor Misconduct Database (FCMD)
The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »
Cardinal Health, Inc.
Failure to Conform to Current Good Manufacturing Practices
Date: 07/10/2001 (Date of Inspection Report)
Misconduct Type: Health
Enforcement Agency: Health and Human Servs.
Contracting Party: None
Court Type: Administrative
Amount: $0
Disposition: Administrative Agreement
Synopsis: 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.
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