Federal Contractor Misconduct Database (FCMD)
Deficiencies in Medical Diagnostic Devices
Abbott Laboratories paid $100 million to resolve allegations that the company’s methods and facilities for manufacturing in vitro diagnostic devices were not in compliance with the U.S. Food and Drug Administration good manufacturing requirements. Abbott also agreed to take specific remedial measures to ensure it came into compliance with FDA regulations and cease manufacturing and distributing almost 300 devices at two facilities in Illinois.
- Misconduct Type
- Enforcement Agency
- Contracting Party
- Court Type
- Date of Settlement Announcement