483
Amerigen Pharmaceuticals Inc.Amerigen Pharmaceuticals Inc. – FDA 483, Jul 27, 2017
Record Details
An FDA inspection of Amerigen Pharmaceuticals Inc. in Lyndhurst, NJ, revealed significant deficiencies in the firm's written procedures for handling post-marketing adverse drug experiences. The company lacked adequate procedures for the surveillance, evaluation, and reporting of adverse drug events to the FDA. This indicates a serious gap in their pharmacovigilance system.
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ID · 0ac14809-47bb-4a47-b131-09b6e4feab39
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