FDA imposes $100 million fine
Abbott Park, Ill-Abbott Laboratories has been fined $100 million by the Food and Drug Administration. The two organizations entered into a consent decree, which does not represent an admission of any violation, but prohibits Abbott from manufacturing or distributing diagnostic products until their Lake County, Ill, manufacturing site conforms with the FDA's Quality System Regulation. The deadline for compliance is one year.
The original decree allowed the products to remain on the market for 30 days, so consumers would have time to find alternate suppliers. However, the US District Court amended the decree upon the request of users and extended the deadline to January 10, 2000. "This decree allows us to resolve these issues comprehensively and systematically without disruption to patient care worldwide. We will work closely and cooperatively with the FDA to ensure our Lake County, Ill, diagnostic manufacturing operations are in full and complete conformance as rapidly as possible," states Miles D. White, chairman and chief executive officer of Abbott Laboratories. The decree does not affect other Abbott products.
Beyond the Surface: Rethinking Environmental Hygiene Validation at Exchange25
June 30th 2025Environmental hygiene is about more than just shiny surfaces. At Exchange25, infection prevention experts urged the field to look deeper, rethink blame, and validate cleaning efforts across the entire care environment, not just EVS tasks.
A Controversial Reboot: New Vaccine Panel Faces Scrutiny, Support, and Sharp Divides
June 26th 2025As the newly appointed Advisory Committee on Immunization Practices (ACIP) met for the first time under sweeping changes by HHS Secretary Robert F. Kennedy Jr, the national spotlight turned to the panel’s legitimacy, vaccine guidance, and whether science or ideology would steer public health policy in a polarized era.
Getting Down and Dirty With PPE: Presentations at HSPA by Jill Holdsworth and Katie Belski
June 26th 2025In the heart of the hospital, decontamination technicians tackle one of health care’s dirtiest—and most vital—jobs. At HSPA 2025, 6 packed workshops led by experts Jill Holdsworth and Katie Belski spotlighted the crucial, often-overlooked art of PPE removal. The message was clear: proper doffing saves lives, starting with your own.