The US Food and Drug Administration (FDA) has banned more products from drugmaker Ranbaxy Laboratories from entering the United States due to manufacturing violations. The FDA on Thursday said Ranbaxy is prohibited from making and distributing pharmaceutical ingredients from its facility in Toansa, India, to prevent substandard quality products from reaching US consumers. The move follows an FDA inspection of the facility which identified significant violations of good manufacturing practices. Staff at the Toansa facility were found to have retested raw materials and other ingredients after the items failed analytical testing in order to produce acceptable findings, and did not report or investigate the failures, the FDA said. Terming the USFDA ban on its Toansa plant disappointing, Ranbaxy Laboaratories on Friday said it will take appropriate management action for the lapses at the manufacturing facility after the conclusion of an internal investigation. The company is disappointed with the recent US Food and Drug Administration (USFDA) action and would like to apologise to all its stakeholders for the inconvenience caused by the suspension of shipment, Ranbaxy Laboratories said in a statement. This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation, Ranbaxy CEO and Managing Director Arun Sawhney said. The ban is the latest in a series of measures taken by the FDA to keep substandard products made by Ranbaxy out of the US market. The FDA previously banned products from the companys facilities in Paonta Sahib, Dewas and Mohali as part of a consent decree designed to ensure compliance with good manufacturing practices. The FDAs latest move means Ranbaxys products are all but entirely banned from the United States.
Posted on: Sun, 02 Feb 2014 05:08:21 +0000