FDA's Improved Forensics Uncovers More Manufacturing Data Integrity Issues
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.
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The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.
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