Regulatory Focus™ > News Articles > Four Disbarred By FDA Over Egregious Quality Mishaps

Four Disbarred By FDA Over Egregious Quality Mishaps

Posted 10 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) took the "rare step" to disbar four quality control professionals formerly employed by the now-defunct genomics company Able Laboratories, reports Fierce Pharma Manufacturing and Pharmalot.

According to The Federal Register the four are banned from "providing services in any capacity to a person that has an approved or pending drug product application," effectively severing them from the pharmaceutical industry. Companies found to be employing any of the four will also be subject to financial penalties and the rejection of their drug application submissions.

Those disbarred include Shashikant Shah, former vice president of quality control and regulatory affairs for Able Laboratories, who was also sentenced to 18 months in jail for charges related to a litany of quality infractions.

"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," writes Pharmalot.

Read more:

Pharmalot - Disabled: FDA Debars Former Able Lab Employees

Fierce Pharma Manufacturing - FDA disbars 4 quality control execs from defunct Able Laboratories

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