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FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

Apr 28th, 2014

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FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture.

Since the middle of 2013, seven Indian firms have received warning letters referencing the integrity of their records, procedures, and interactions with FDA investigators.

Those letters followed in the wake of an equal number of warnings issued from the beginning of 2012 to mid-2013 addressing integrity problems, three of which involved plants in India.

[Editor’s Note: For an in-depth analysis of the drug GMP warning letters issued by FDA from 2012 through mid-2013 that reference data integrity see IPQ August 22, 2013. The story focuses in particular on the issues that surfaced during that time frame at RPG, Fresenius Kabi, Wockhardt, and Ranbaxy.  A listing of all 14 of the letters from 2012 through April 2014 that cite data integrity is provided below.  The earlier IPQ coverage extended through the letter issued to Wockhardt in mid-July 2013.  The Aarti Drugs letter in the listing was issued in late July 2013 and was not part of the earlier coverage.]

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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