Abbott faces $15,000 daily FDA fine

Medical Marketing and Media, Jun 2000 by Dickinson, James G

The FDA is contemplating $15,000-a-day penalties against Abbott Laboratories for failing to meet its March 1 deadline for compliance under a consent decree with the agency last November over manufacturing problems at its diagnostics facility in Lake County, Ill. The fine could be levied for Abbott's failure to bring its Corrective and Preventive Action (CAPA) system into compliance with the FDA's Quality System Regulation within 120 days of the decree.

The FDA recently inspected the firm after Abbott's expert consultants, Quintiles Inc., provided the agency with an audit report certifying that the firm was meeting the decree's CAPA conditions. The FDA inspection, however, documented continued deficiencies with the firm's CAPA system, a high FDA official said. Abbott has responded to the inspections FDA-483, and the fine is on hold until FDA completes its evaluation.