Dako Denmark A/S – FDA Warning Letter, Mar 14, 2013

An FDA inspection of Dako Denmark A/S in Glostrup, Denmark, from March 11-14, 2013, revealed that the firm's HER2 CISH pharmDx kit and other devices are adulterated. The manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). The FDA identified four primary violations. First, the firm failed to establish and maintain adequate procedures for corrective and preventative actions (21 CFR 820.100(a)), specifically closing CAPAs without objective evidence of effectiveness checks and not assessing adverse effects on finished devices. Second, there was a failure to ensure process validation with a high degree of assurance when results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), with deficiencies noted in a process validation protocol. Third, the firm lacked adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), failing to follow its own complaint procedure for data searches, not documenting repairs as complaints, and not determining if service calls were medical device reportable events. Finally, Dako failed to establish and maintain adequate procedures for identifying valid statistical techniques for process capability and product characteristics, lacking statistical rationale for monitoring periods. The firm's April 2, 2013, response was deemed inadequate for most observations, lacking sufficient evidence of implemented corrections and systemic actions. The FDA warns of consequences including impacts on federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments. Dako must provide a written response within fifteen business days detailing corrective and preventative actions, including a timetable for completion.