Novo was cited for failing to collect enough environmental monitoring samples, according to the letter released Tuesday , which was related to a series of inspections from March at a plant in Denmark. “This substantial number of missed samples suggests a pattern that raises concerns regarding your environmental program,” the FDA wrote.
The company’s quality unit also failed to investigate and quantify the impurity peak during its high-performance liquid chromatography analysis. The FDA sought a diagram describing the positioning of each non-viable particle monitoring probe on the filling line and a justification for each position.
But Ken Inchausti, spokesman for Novo, told In-Pharmatechnologist.com that the warning letter will not have “any impact on the supply” of its insulin and Victoza products because the plant is a backup. The company’s primary plant is in Clayton, N.C. He also said that the letter won’t create production issues at other neighboring plants near the company’s headquarters and that it responded to the FDA letter in late December.
The Novo Nordisk “quality system is robust [as] shown by our long track record of passing inspections – just this year we have passed 100 inspections conducted by a number of regulatory agencies,” Inchausti said.
Foreign Warning Letters
The release of three cGMP-related warning letters at foreign facilities in January alone shows that the FDA is taking foreign inspections more seriously. Previously released letters for manufacturers in Taiwan and Germany cited insufficiencies in validating manufacturing processes and sterilization processes. All three letters were issued within five days of each other.
By comparison, the FDA sent only five warning letters to foreign manufacturers in 2008 and 19 in 2009. At the current pace, the FDA could end up sending more than 35 foreign warning letters in 2013.