FDA issued a warning letter to Sun Pharmaceuticals in early May in the wake of a November 2013 inspection that found data integrity problems at the firm’s Karkhadi, India API facility, which resulted in it being placed on FDA’s import alert list in March. Integrity concerns cited at the facility included: lack of raw data, “unofficial testing” of samples, and failure to identify raw materials. Earlier this year Sun bought Ranbaxy, which had also been enmeshed in data integrity problems with the agency. [See IPQ April 28, 2014 and August 22, 2013 for more on FDA’s findings of data integrity problems in India.]
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