FDA 483 - Novo Nordisk A/S - 25a-B - January 17, 2020

During an FDA inspection conducted from January 15-17, 2020, Novo Nordisk A/S, a control testing laboratory in Varløse, Denmark, received an FDA Form 483. The inspection highlighted a significant observation related to the firm's investigation procedures for unexplained discrepancies, which are critical under regulatory frameworks governing pharmaceutical quality control.

Specifically, the FDA noted that Novo Nordisk failed to conduct a thorough root cause investigation into unknown peaks repeatedly detected during High-Performance Liquid Chromatography (HPLC) analysis of a drug product. These peaks were observed between August 2018 and March 2019. Despite suggesting these were due to "sample contaminations," the company decided against further investigation. Instead, their internal report concluded that analysis could proceed, with instructions that the extra peak "should not be integrated" if observed.

As a corrective measure, Novo Nordisk updated its analysis method to describe how to handle the extra peak. A new internal procedure, Q196116 Ver 8.0, reflecting these changes, was implemented in December 2019. The FDA 483 serves as a formal notice of these observations, requiring Novo Nordisk to address the identified deficiencies in its quality control and investigation systems.