Seven years ago, a little-known generic drugmaker landed on the national radar screen in a big way. Able Laboratories was cited by the FDA for all sorts of serious problems that resulted in one of the largest product recalls ever, and the implications were widespread since the drugmaker made billions of tablets and capsules for treating high blood pressure and chest pain, among numerous other ailments. Among the infractions: routinely retesting samples that failed quality control tests until they passed; failing to report results when drugs failed potency or other tests, and reporting only passing test results, but not failures, after receiving FDA permission to halt a quality-control test. The culprits included Able executives, supervisors and lab analysts (here is the 483 report). In 2007, several people pleaded guilty to the scheme and implicated the former ceo (back story).
