FDA 483 - Novo Nordisk US Bio Production Inc. - February 14, 2020

An FDA inspection of Novo Nordisk US Bio Production Inc. in West Lebanon, NH, a drug substance manufacturing facility, revealed significant deficiencies in quality control. Observations included inadequate laboratory controls for microbial detection, insufficient in-process hold time studies, and scientifically unsound corrective actions. Additionally, the firm failed to follow written procedures for contaminant identification and had inadequate written procedures for OOS investigations and employee training.