Ranbaxy ready for re-inspection
This article was originally published in The Gold Sheet
Executive Summary
Ranbaxy has asked FDA to re-inspect its Paonta Sahib and Dewas manufacturing sites in India, CEO Atul Sobti told PharmAsia News. The company has provided the agency a report explaining how it corrected problems FDA noted in previous inspections, and which led the agency in September to suspend imports of more than 30 products. A favorable re-inspection could enable Ranbaxy, now owned by Japanese drug maker Daiichi Sankyo, to resume U.S. exports (see "The Gold Sheet," March 2009, p. 11 and "The Gold Sheet," August 2008, p. 6)
You may also be interested in...
Time Waits for No Lab, Ranbaxy Learns
Time waits for no lab learn Ranbaxy and new owner Daiichi Sankyo as stock sinks after FDA sanctions firm for holding stability testing samples in refrigerators until its overworked lab could get around to testing them. Lab was backdating same-day testing of 30-, 60- and 90-day samples, FDA said as it slapped Ranbaxy with application integrity letter.
Ranbaxy Internal Audit Disclosure Highlights FDA Policy Exceptions
FDA went to court for a look at Ranbaxy’s internal audits despite its longstanding policy against routinely reviewing such documents. However, a 1996 revision made exceptions for cases like Ranbaxy’s, in which the agency is pursuing allegations of fraud.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.