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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.