Agilent Technologies Announces Resolution to U.S. FDA Warning Letter for Dako Denmark
April 22 2015 - 04:05PM
Business Wire
FDA Completes Evaluation in Denmark,
Indicates Issues Have Been Addressed
Agilent Technologies Inc. (NYSE:A) today announced that its
subsidiary, Dako Denmark A/S, has received a close-out letter from
the U.S. Food and Drug Administration with respect to the warning
letter issued Aug. 21, 2013. The FDA informed Dako Denmark that it
has completed its evaluation of Dako’s corrective actions and that
it appears Dako has addressed the violations contained in the
warning letter.
The warning letter, issued by the FDA’s Center for Devices and
Radiological Health, focused on Dako’s quality management processes
for complaint handling, corrective and preventive actions,
statistical techniques and process validation. The letter was the
result of an inspection the FDA performed at Dako’s facility in
Glostrup, Denmark, in March 2013.
“We are pleased with this outcome,” said Agilent President and
CEO Mike McMullen. “It underscores our commitment to maintaining a
compliant and superior quality management system, and to delivering
products that are of the highest quality.”
About Agilent Technologies
Agilent Technologies Inc. (NYSE:A), a global leader in life
sciences, diagnostics, and applied chemical markets, is the premier
laboratory partner for a better world. Agilent works with customers
in more than 100 countries, providing instruments, software,
services, and consumables for the entire laboratory workflow.
Agilent generated revenues of $4.0 billion in fiscal 2014. The
company employs about 12,000 people worldwide. Information about
Agilent is available at www.agilent.com.
NOTE TO EDITORS: Further technology, corporate citizenship and
executive news is available at www.agilent.com/go/news.
EDITORIAL CONTACTS:Agilent Technologies Inc.Michele Drake, +1
408-345-8396michele_drake@agilent.comorVictoria Wadsworth-Hansen,
+45 2933 6980victoria.wadsworth-hansen@agilent.comorINVESTOR
CONTACT:Alicia Rodriguez, +1
408-345-8948alicia_rodriguez@agilent.com
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