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JAMA. 2000;283:46.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Abbott Laboratories, Abbott Park, Ill, has entered into a consent decree of permanent injunction with the Department of Justice affecting 242 in vitro diagnostic devices manufactured by Abbott's Diagnostic Division in Abbott Park and its K2 facility in North Chicago, Ill. A total of 178 of these devices that the FDA identified as medically necessary continue to be available while their manufacturing is being brought into compliance with the FDA's Quality System regulation; the remaining 64 devices will not be distributed following a transition period to allow users to standardize or obtain alternative test methods.

The FDA requested the permanent injunction after Abbott failed to comply with FDA requirements. Since 1993, numerous FDA inspections of the firm's facilities have identified problems with process validation, the corrective and preventive action system, and production and process controls. These shortcomings can adversely affect product performance. Three FDA warning letters and other efforts over . . . [Full Text of this Article]

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