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www.fdanews.com/articles/169076-fda-inspection-gave-beleaguered-gvk-bio-plant-clean-bill-of-health

FDA Inspection Gave Beleaguered GVK Bio Plant Clean Bill of Health

December 12, 2014

A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with U.S.-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors.
Drug Industry Daily