By Lewis, Carol
FDA Consumer , Vol. 34, No. 3
For failing to correct long standing manufacturing violations, the nation's largest maker of laboratory diagnostic tests paid the heftiest sum ever sought by the Food and Drug Administration.
Abbott Laboratories, a multinational pharmaceutical and medical supply giant in Chicago, and two of its top corporate executives, Miles D. White and Thomas D. Brown, agreed on Nov. 4, 1999, under a consent decree of permanent injunction, to pay $100 million and to stop making and selling many of its 225 in vitro diagnostic tests until it corrects long standing manufacturing problems. In vitro diagnostic tests are performed in laboratories on samples of patients' blood, urine, mucus, and other bodily fluids, and are used in diagnosing disease to determine the appropriate treatment.
Abbott failed both to comply with FDA's Current Good Manufacturing Practice (CGMP) regulation, now called the Quality System (QS) regulation, and to fulfill past commitments to correct existing deficiencies. Under the decree, Abbott was required to halt the manufacture and distribution of tests not medically necessary (those used for diagnosing less serious conditions) in the United States after Jan. 10, 2000.
FDA first raised concerns about Abbott's manufacturing practices in 1993, when routine inspections of the firm's facilities uncovered violations in process validation (a system that assures a product will consistently meet its predetermined specifications and work the way it is supposed to work), production and process controls, and corrective and preventive actions.
Following these inspections, FDA sent a warning letter to Abbott in October 1993, detailing the problems found. A subsequent inspection of the firm's facilities identified similar manufacturing problems, and a second warning letter was issued in March 1994. In 1995, Abbott agreed to a voluntary compliance plan to correct the problems. However, subsequent FDA inspections during 1997 and 1998 revealed the same types of deficiencies. FDA sent another warning letter in March 1999, when the firm failed to meet promised completion dates and to correct problems adequately.
The most recent inspection, which concluded on July 8, 1999, again revealed that the company was not in compliance with the CGMP/QS regulation, and that previous problems had not been corrected. At that time, FDA sought a court order to force the firm to bring its processes into compliance in a timely fashion.
The consent decree, signed by Judge Harry D. Leinenweber in Chicago, was not the first action FDA has taken against Abbott for production problems. In November 1998, the agency became concerned about an Abbott prescription drug called Abbokinase (urokinase) because of serious deficiencies in its manufacturing process, the testing of the product, and the screening and testing of the donors of kidney cells used to make the drug. …