FDA Completes Evaluation in Denmark, Indicates Issues Have Been
Addressed
SANTA CLARA, Calif.--(BUSINESS WIRE)--Apr. 22, 2015--
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.
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Source: Agilent Technologies Inc.
EDITORIAL CONTACTS:
Agilent Technologies Inc.
Michele Drake,
+1 408-345-8396
michele_drake@agilent.com
or
Victoria
Wadsworth-Hansen, +45 2933 6980
victoria.wadsworth-hansen@agilent.com
or
INVESTOR
CONTACT:
Alicia Rodriguez, +1 408-345-8948
alicia_rodriguez@agilent.com