The FDA issued the import alert for the Mohali, India-based facility after discovering cGMP (current good manufacturing practice) violations. The site is also now subject to terms of the consent decree that the company agreed to in January 2012.
But the import alert for the Mohali site seems to have come as a surprise for the generic drug manufacturer. Ranbaxy spokeswoman Sharon Santacroce told In-Pharmatechnologist.com, “Concerning Mohali, we have so far not received any communication from the U.S. FDA on this subject. We are seeking information from the US FDA in this regard.”
FDA spokesman Stephen King assured us that the FDA notified Ranbaxy of the alert.
The US agency also noted that inspections from September and December 2012 identified significant cGMP (current good manufacturing) violations at the Mohali facility, including “failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.”
The import alert also may throw a wrench in the company’s plans to manufacture valsartan, the generic version of Novartis’ heart drug Diovan, according to industry blog Pharmalot.
The consent decree also calls for cGMP compliance at other Ranbaxy facilities in Paonta Sahib and Dewas, India, and it addresses data integrity issues at those two facilities. Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008. Company spokesman Chuck Caprariello previously told us that the company retained cGMP consultants for the Paonta Sahib and Dewas sites to review its manufacturing practices there.
The violations at the Mohali site are the latest in a long list of manufacturing issues for Ranbaxy, which earlier this summer plead guilty to manufacturing adulterated drugs, according to a settlement with the US DOJ (Department of Justice).
In addition, in December 2012, the company’s New Jersey-based plant experienced quality issues that caused it to halt Lipitor generic manufacturing.