483
AMARIN PHARMACEUTICALS, INCAMARIN PHARMACEUTICALS, INC – FDA 483, Jun 4, 2001
Record Details
An FDA inspection of Amarin Pharmaceuticals, Inc. in Warren, NJ on June 4, 2001, identified one observation. The firm was cited for an inadequate written procedure regarding the surveillance, receipt, evaluation, and reporting of adverse drug experiences. This indicates a deficiency in their pharmacovigilance processes.
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ID · cdb13607-5ea0-41ca-aa68-bbeac0d0f363
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