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