FDA 483 - Adamas Pharmaceuticals, Inc. - June 28, 2021

Adamas Pharmaceuticals, Inc. in Emeryville, CA, was inspected regarding its sponsor activities. The inspection revealed a significant deficiency in the firm's pharmacovigilance system, specifically the failure to develop and approve written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences. This lack of procedures, including for vendor oversight and reconciliation, potentially jeopardized patient health.