Dako got hit with an FDA citation over what the agency says are quality system manufacturing violations involving one of its signature breast cancer diagnostic kits and other related products.
In a warning letter dated Aug. 21, 2013, regulators knocked the Danish diagnostics maker for not having a framework in place to correct manufacturing problems and prevent future ones. The FDA also criticized the company for not following its own procedures for documenting complaints, or how it responded to them.
FDA inspectors developed their list of complaints based on a run-through of the company's Glostrup, Denmark, facility in March of this year. The facility makes Dako's HER2 CISH pharmDx kit, plus other FDA-cleared products, regulators note in their letter. Dako's product is a companion diagnostic meant to assess patients for Roche/Genentech's Herceptin.
Dako has 15 business days to reply to the letter from the date the company received it. And the FDA said it wants to hear about steps Dako has taken to correct the noted violations and how it will prevent them in the future.
The warning letter is a blip in Dako's otherwise steady molecular diagnostics growth in recent months. In April, for example, the company won FDA clearance to start selling a new monoclonal antibody for breast cancer diagnostics known as Clone EP1 (Epitomics developed it and Dako is selling it as part of a 2011 collaboration deal.). Separately, Dako has forged companion diagnostics partnerships with a number of Big Pharma players, including Roche ($RHHBY), Eli Lilly ($LLY), and Pfizer ($PFE). Dako has plowed ahead with a molecular diagnostics growth strategy following Agilent Technology's $2.2 billion purchase of the company in May 2012.
- here's the FDA warning letter