FDA 483 - Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc. received a Form 483 for significant deficiencies in their bioresearch monitoring practices, including a repeat observation for failing to ensure proper study monitoring and enrolling ineligible subjects. The firm also failed to manage a non-compliant clinical investigator effectively and did not ensure proper retention and integrity of electronic records. These issues indicate serious concerns regarding the conduct and oversight of clinical trials.