FDA nails Novo for missing 850 samples over 2 years

While most of the discussion of stepped-up inspections by the FDA of foreign manufacturing plants is about the need to keep track of China, it does not mean the industry's biggest players will escape tough oversight. Just ask Novo Nordisk.

The FDA today posted a scathing warning letter sent in December to Novo Nordisk ($NVO) about a plant in Novo Alle, Bagsvaerd, Denmark. The FDA says that over two years the plant failed to collect nearly 850 samples for environmental testing. The Swedish insulin specialist could not be reached for comment, but in issuing its earnings report recently it acknowledged the letter and said, "Novo Nordisk does not expect the letter to have an impact on products currently marketed in the U.S."

The FDA said it was particularly troubled that the plant had missed 846 scheduled environmental monitoring (EM) samples from March 2010 to February 2012 during the manufacture of sterile products. It said it does not understand why the operation has been unable to get on top of the issue, and Novo's quality-control operation agreed to release product to the U.S. under the circumstances.

The plant was also criticized for the fact that it had not thoroughly investigated batch failures. The agency was not satisfied with the response that those failures were tied to another product made on the same line that "tends to adhere to surfaces in the HPLC injection system." The letter says the FDA is "concerned that no investigation was conducted until this situation was brought to your attention by our investigator" and that the quality-control laboratory was approving the HPLC analyses without initiating a formal investigation into this "unknown" peak. Other problems were also pointed out in sterility sampling and equipment.

The issue of how often and how rigorously the FDA was able to inspect foreign plants led in part to fees on generic drugmakers to help cover the cost of more inspectors able to oversee operations throughout the world. With extra money, the FDA expects to step up foreign plant inspections, particularly in places like mainland China where thousands of plants are now operating and offering bulk APIs online. But with the ever-expanding number of operations, the agency is also looking for ways to work cooperatively with regulators from other countries. The new law will also allow the most trusted drugmakers to hire nongovernment inspectors to assess whether factories are meeting U.S. quality standards and offer their data to the FDA as support of the companies' manufacturing processes.

- here's the warning letter
- read the earnings release

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