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FDA Issues Warning Letter to Agilent's Dako

NEW YORK (GenomeWeb News) – The US Food and Drug Administration issued a warning letter to Agilent Technologies' Dako business, saying the company's HER2 chromogenic in situ hybridization, or CISH, pharmDx test and other products do not conform to federal current good manufacturing practice requirements.

In a letter dated Aug. 21 and released by FDA on Monday, the agency said that it found the problems during an inspection of Dako's facility in Glostrup, Denmark in March. Among the violations cited in the warning letter is one saying Dako failed "to establish and maintain adequate procedures for implementing corrective and preventative action" as required.

For example, FDA said, Dako closed six corrective/preventive actions "documenting the actual corrective actions taken as the effectiveness check." However, FDA said that there was no "objective evidence" that the six actions were effective.

Additionally, Dako said in its documentation that verification of the actions would be continued through a quality plan that "was not approved until after the [corrective/preventive actions] were closed." FDA approved the quality plan this past March, but the six corrective/preventive actions closed between November 2011 and April 2012, FDA said in the warning letter.

The agency also said that when a subsequent FDA inspection and test was not able to fully verify the results of a process, Dako did not ensure that the process would be validated "with a high degree of assurance" and approved according to established procedure, as required by federal codes.

FDA further said that Dako did not handle customer complaints properly and failed "to establish and maintain adequate procedures for receiving, reviewing, and evaluating complains by a formally designated unity," as required.

Lastly, the agency said that Dako did not create and maintain adequate methods of identifying "valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics."

Dako responded in April to problems that were brought to the company's attention by an FDA inspector, but the agency said that the responses were either inadequate or that the response's adequacy could not be yet determined pending further action by Dako.

FDA said that US federal agencies may be advised that warning letters have been issued and that this may be taken into consideration in the awarding of contracts. Further, premarket approval applications for Class III devices will not be approved until the violations which led to the warning letter have been corrected. Requests for certificates to foreign governments will also not be granted until the violations are corrected, FDA said.

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