The QMN Weekly Bulletin

FDA Flags Environmental Controls Errors

Feb. 8, 2013

Environmental controls at Novo Nordisk’s aseptic filling facility in Bagsvaerd, Denmark, are not consistently implemented and may have resulted in distribution of contaminated sterile drugs, an FDA warning letter states.

The warning follows the Danish drugmaker’s inadequate response to two observations made during an inspection of the plant in March 2012, the agency said in a letter.

FDA investigators flagged plant personnel for failing to collect more than 800 scheduled environmental monitoring (EM) samples of sterile drugs over a two-year period. Such collections are critical to any aseptic facility’s environmental program, and the number of samples missed suggests a disconcerting “pattern” of EM laxity at the plant, the letter states.

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