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FDA's Improved Forensics Uncovers More Manufacturing Data Integrity Issues

 
• By Brenda Sandburg

Agency learned how to find hidden information during its investigation of Ranbaxy, with techniques including improved forensic examinations of firm computers; mock inspections held at Indian and Chinese sites ahead of FDA visits.

As FDA steps up inspections of drug manufacturing plants in India and China, companies are holding mock inspections and bringing in outside consultants and lawyers to detect problems.

Douglas Farquhar, a director at Hyman, Phelps and McNamara who has helped numerous firms prepare for inspections, said the goal is to cure a problem before the inspection occurs. And...

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