483
Supernus Pharmaceuticals, Inc.FDA 483 - Supernus Pharmaceuticals, Inc. - February 03, 2017
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Record Details
Supernus Pharmaceuticals, Inc. in Rockville, MD, was inspected regarding its analytical laboratory operations. The inspection revealed a significant issue with the timely submission of quarterly periodic adverse drug experience reports (PSURs) for its products Trokendi XR and Oxtellar XR. Approximately 40% of all PSURs for these products were submitted late to the FDA.
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ID · 1869cce8-730f-465f-a5b7-3dae643d1f96