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.