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Dako Resolves Issues Raised in 2013 FDA Warning Letter

NEW YORK (GenomeWeb) – Agilent Technologies said after the close of the market on Wednesday that its subsidiary Dako Denmark has received a close-out letter from the US Food and Drug Administration, bringing an end to issues that were raised during an inspection in 2013. 

Agilent said that the FDA has told Dako that it has completed its evaluation of the company's corrective measures and it appears Dako has addressed the violations contained in a warning letter that it received Aug. 21, 2013. The warning letter resulted from an inspection that the FDA conducted of Dako's facility in Glostrup, Denmark in March of that year.

At the time, FDA told Dako that its HER2 chromogenic in situ hybridization pharmDx test and other products did not conform to federal current good manufacturing practice requirements, including failure to "establish and maintain adequate procedures for implementing corrective and preventative action," as required.