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

Agilent Technologies (NYSE:A)
Historical Stock Chart
From Feb 2024 to Mar 2024 Click Here for more Agilent Technologies Charts.
Agilent Technologies (NYSE:A)
Historical Stock Chart
From Mar 2023 to Mar 2024 Click Here for more Agilent Technologies Charts.