Dirty Goggles Tripping Up Novo Nordisk
February 7th, 2013 // 4:14 pm @ jmpickett
No, this is not about making fashion statements. The FDA is taking Novo Nordisk to task for a bunch of problems at a key facility near its Denmark headquarters. Specifically, the agency inspected the plant last year and found employees were wearing goggles that were not sterilized and also had two openings at the top, suggesting concerns over contamination, according to a newly posted warning letter sent to the drugmaker.
The warning letter, which was actually issued last December, also details a failure to collect hundreds of environmental monitoring samples, which raised “concerns†about its monitoring program, and another failure to investigate and quantify an impurity found during a high-performance liquid chromatography (HPLC) analysis of various batches of unspecified medications.
Of course, the FDA issues warning letters on a regular basis, but what is interesting is that this letter focuses, in part, on impurities in injectable medicines, an issue that has resonated widely and deeply after the scandal at the New England Compounding Center, which was at the center of a nationwide outbreak of fungal meningitis. The FDA is under fire from a Congressional committee for not doing more to regulate NECC (see this).
Moreover, the Novo facility under scrutiny is not in a distant land, but close to corporate headquarters. Quality control problems can and do appear at every facility, but the fact that these occurred so close to home may prompt the FDA to wonder what is going on at more far-flung plants. The agency, you may recall, has recently taken what might be considered a more holistic approach toward specific companies, including Novartis and Merck KGga (read here and here).
In response, Novo (NOV) issued a statement saying the letter is related to “a current Good Manufacturing Practice (cGMP) inspection of a filling plant in Bagsværd, Denmark. The company submitted its response to the Warning Letter on December 28, 2012. Novo Nordisk does not expect the letter to have an impact on products currently marketed in the US.†A Novo spokesman adds that “we take the observations seriously and we’re working to appropriately address the issues raised.†You can read the warning letter here.
