Novo Nordisk A/S – FDA Warning Letter, Mar 20, 2012

This FDA Warning Letter, dated December 12, 2012, was issued to Novo Nordisk A/S following a March 12-20, 2012 inspection of their Bagsvaerd, Denmark pharmaceutical manufacturing facility. The inspection identified significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination in sterile drug products (21 CFR § 211.113(b)):** * Approximately 846 environmental monitoring (EM) samples were not collected in Class 100 (Grade A) and Class 10,000 (Grade C) areas from March 2010 to February 2012 during sterile product manufacture. The firm's response regarding "missed" or "invalidated" samples was deemed insufficient. * Operators in the aseptic core wore goggles that were not adequately sterilized and had two openings. The firm's disinfection qualification for goggles was inadequate, and the proposed redesign did not address protective venting. * Non-viable particulate environmental monitoring was performed too far from the aseptic fill line's filling station, lacking scientific justification for the chosen location.

2. **Failure to thoroughly investigate batch failures (21 CFR § 21