Ranbaxy Facility Banned from Producing FDA-Regulated Drugs

The Food and Drug Administration has issued an import alert and banned a facility in Mohali, India, from producing FDA-regulated drugs. Ranbaxy, an Indian generics manufacturer, was the subject of two 2008 warning letters from the agency, citing serious manufacturing deficiencies. Two other Ranbaxy facilities have been on an import alert since then. In May of this year the company pled guilty to federal drug safety violations after making false statements to the FDA, and paid $500 million in fines to settle the claims. At that time the company acknowledged it did not conduct safety and quality tests on certain drugs.

The current alert allegedly stems from an FDA inspection of the facility that turned up suspected hairs in drugs, oil from machines in drugs, and lack of running water in the facility’s restrooms. The facility was inspected by the terms of a 2012 consent decree of a permanent injunction entered against the company. The degree contained provisions to ensure Ranbaxy followed current good manufacturing practices.

Ranbaxy must hire a third party expert to conduct an inspection of the Mohali facility and certify to the FDA that the facilities, methods, processes and controls are adequate to ensure continuous compliance with the current good manufacturing practice. When the FDA is satisfied of compliance it will permit the company to resume manufacture and distribution of FDA-regulated drugs.

The company’s response stated:

Ranbaxy will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest.

The US FDA had conducted inspections at Ranbaxy’s Mohali facility in 2012, resulting in certain observations. The Company believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the US FDA. Ranbaxy is hopeful of an early resolution of these concerns.