FDA Cites Another Indian Drugmaker For Suspect Records

Law360, New York (March 25, 2014, 2:04 PM EDT) -- The U.S. Food and Drug Administration on Tuesday published a warning letter accusing Indian drugmaker Smruthi Organics Ltd. of bogus record-keeping surrounding production of active pharmaceutical ingredients, adding to several recent enforcement actions involving alleged data manipulation.

In its sharply worded letter, the FDA cited an array of suspicious findings from an October inspection, included certain records in which employees attested to having performed various activities on specific days despite other documents showing them as absent from work on the days in question.

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