Call it a truce between Ranbaxy Laboratories and U.S. law enforcement. The Department of Justice has dropped its legal action against Ranbaxy, now that the company has agreed to hand over audits of its manufacturing facilities. For months the FDA has been trying to get the documents as part of an inquiry into allegations that the company falsified records, allowing the company to sell substandard generic meds.
Ranbaxy claimed the audits--conducted by Parexel--were privileged info. The FDA struck back, banning nearly 30 Ranbaxy products from entering the U.S., citing two Ranbaxy plants in India for inadequate manufacturing controls and procedures.
Since then, Ranbaxy hired former NYC mayor Rudy Giuliani for advice. And now, the cease fire. Presumably we'll eventually find out what those contested audits actually reveal.
- read the item at Pharmalot