Sun 13 Jul 2008
The US FDA investigated Ranbaxy’s Paonta Sahib manufacturing plant three years ago. The plant was blocked from sending products into the US, as several lapses in records and manufacturing processes were detected and 483s issued. Then, a year later in 2007 federal investigators raided Ranbaxy’s US office and we could only guess what it could be all about. But, now its getting very very clear.
The US FDA has filed a 28 page Motion in the Maryland District Court, its headquarters, against Ranbaxy. There are various charges, some of them as serious as “systematic fraudulent conduct”. The FDA has also dragged consulting firm Parexel to court, which was hired by Ranbaxy to straighten up things at the Paonta Sahib plant.
The case was filed on July 3 and all of that came to light with this investigative report filed by George J Jordan of Star-Ledger. Extra-ordinary report, by George !