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483
•Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc. – FDA 483

Record Details

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.

Company
Acadia Pharmaceuticals Inc.
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
People
  • Lakecha N. Lewis (Business Analyst/Provider Enrollment Specialist)
  • Kaitlyn T. Dang (issuing_officer)
View Company Profile

ID · 47942bac-9cd9-446e-a5f4-82fdeae3dcd0

Other documents for Acadia Pharmaceuticals Inc.
  • EIR - 2016-02-17February 17, 2016

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