Generic drug manufacturer Ranbaxy USA Inc. has agreed to pay $500 million to settle criminal and civil allegations that the company manufactured and distributed adulterated drugs. The company pleaded guilty to three felony counts of introducing adulterated drugs into interstate commerce and four felony counts of making false statements to the FDA. The drugs were adulterated because Ranbaxy failed to comply with the current Good Manufacturing Practice requirements (“cGMPs”) established by the FDA. Because Ranbaxy’s facilities did not comply with the cGMPs, the safety and quality of the drugs manufactured there could not be assured.

Ranbaxy acknowledged that its testing records were incomplete and that its program to assess the stability of its drugs was inadequate. Ranbaxy also admitted that it failed to file field alerts for drugs that were found to break down too quickly. For example, Ranbaxy continued to distribute one drug, used to treat acne, for thirteen months after it had failed stability testing. With respect to another drug, used to treat epilepsy and nerve pain, Ranbaxy waited several months before issuing a recall.

Read the entire press release, “Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA”