FDA Clears Division of Agilent Technologies After Warning Letter

The Dako Denmark A/S subsidiary of Agilent Technologies Inc., has received a closeout letter from the U.S. Food and Drug Administration (FDA) regarding a warning letter issued Aug. 21, 2013. The FDA informed Dako Denmark that it has completed its evaluation of the company’s corrective actions and it appears that 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.”

Santa Clara, Calif.-based Agilent Technologies manufactures measurement instruments and equipment for life sciences, medical diagnostics, and chemistry applications.