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Agilent Receives Close-out Letter from FDA

Dako completes corrective actions following Warning Letter

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By: Kristin Brooks

Managing Editor, Contract Pharma

Dako Denmark, an Agilent Technologies company, has received a close-out letter from the U.S. FDA regarding the warning letter issued in August 2013. The FDA has completed its evaluation of Dako’s corrective actions addressing the violations, which focused on quality management processes for complaint handling, corrective and preventive actions, statistical techniques and process validation. The letter followed an inspection at Dako’s facility in Glostrup, Denmark, in March 2013. 
 
“We are pleased with this outcome,” said Agilent president and chief executive officer 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.”

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