ABBOTT LABORATORIES' DIAGNOSTIC MANUFACTURING OPERATIONS IN SUBSTANTIAL CONFORMITY WITH QUALITY SYSTEM REGULATION
Abbott Park, Illinois, December 18, 2003 — Abbott Laboratories today announced that it has received the U.S. Food and Drug Administration (FDA) determination letter concerning Abbott's Lake County, Illinois, diagnostic manufacturing operations. The FDA indicated that Abbott's processes are in substantial conformity with the Quality System Regulation (QSR). This follows an inspection of the Lake County diagnostic manufacturing operations, and is related to a consent decree between Abbott and the FDA. The FDA has classified the outcome of this inspection as "Voluntary Action Indicated," which means the FDA has determined there are follow-up actions that the company needs to take, but that the agency has determined the company can remedy itself.
"The FDA's decision clearly reflects our employees' hard work and Abbott's commitment to bringing its Lake County diagnostic manufacturing operations into conformity," said Miles D. White, chairman and chief executive officer, Abbott Laboratories.
Now that the Lake County diagnostic manufacturing operations have been found in substantial conformity, Abbott can start the process to reintroduce products that were removed from the market in 2000 as a result of the consent decree. The company can also begin the process of introducing new products. Upon FDA’s release, product introductions will resume on a rolling basis throughout the next 12 months.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries. In 2002, the company's sales were $17.7 billion.
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