Letter to Abbott Laboratories

DEPARTMENT OF HEALTH & HUMAN SERVICES
	Office of the General Counsel Office of the Chief Counsel Food and Drug Administration 5600 Fishers Lane, GCF-1 Rockville MD 20857

December 18, 2003

Via Facsimile and U.S. Mail
Abbott Laboratories and
Miles D. White, Chairman and Chief Executive Officer
Abbott Laboratories
One Abbott Park Road
Abbott Park, IL 60064-3500

Thomas D. Brown
President (Retired), Abbott Diagnostics Division
Abbott Laboratories
100 Abbott Road AP6C
Abbott Park, Illinois, 60064-6092

Re: United States v. Abbott Laboratories, No. 99-C-7135 (N.D. Ill.)

Dear Messrs. White and Brown:

On October 14, 2003, pursuant to Paragraph 9 of the Consent Decree, Abbott's experts certified that Abbott's methods, processes, facilities, and controls used to manufacture devices at Abbott Park and K2 are operated and administered in substantial conformity with the Quality System Regulation (QS regulation), 21 CFR Part 820. FDA subsequently conducted an inspection of Abbott's facilities from October 28 through November 13, 2003. This letter is to advise Abbott of FDA's decision that Abbott's processes for the products listed in Paragraph 5(A) are in substantial conformity with the QS regulation, pursuant to Paragraph 9 of the Consent Decree.

While FDA is able to make this determination regarding overall operations at Abbott Park and K2, some quality system issues persist and must be addressed. Upon review of the Form FDA-483 (FDA-483), the Establishment Inspection Report, and Abbott's response to the FDA-483 by FDA's Chicago District Office, the Center for Devices and Radiological Health (CDRH), and the Center for Biologics Evaluation and Research (CBER), FDA has classified the outcome of this inspection as Voluntary Action Indicated.

FDA acknowledges that many of the corrective actions put into place to remedy observations seen during the recent inspection have been initiated only recently. These include actions by Abbott to correct and prevent XXXXXXXXXXXXX, to address problems with the XXXXXXXXXXX, and to ensure that in the future XXXXXXXXXXXX will be identified and addressed in a timely manner. FDA will assess these corrective actions during subsequent inspections to evaluate conformity with quality system requirements.

If you have any questions, please contact Mr. Michael Levy in FDA’s Office of Chief Counsel at (301) 827-5087 or Ms. Lorelei Jarrell in FDA’s Chicago District Office at (312) 596-4216.

Sincerely,

Jesse L. Goodman, M.D., M.P.H.
Director, CBER

David W. Feigal, Jr., M.D., Ph.D.
Director, CDRH

John M. Taylor
Associate Commissioner for Regulatory Affairs
United States Food and Drug Administration