FDA Slaps Novo Nordisk With 483 for Sterility Issues

April 29, 2016

The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures.

During the Oct. 19 to 28 and Nov. 6, 2015 inspection, investigators observed inadequate microbial controls during the manufacture of a factor VII drug substance, including no bacterial endotoxin testing.

Bottles also were not disinfected properly, and investigators noted that there were inadequate controls over unlabeled and labeled drug products. In addition, there were no written instructions describing the procedures for issuing and receiving labels on the packaging line.

Inspectors also cited the company for inadequate corrective and preventive actions. For example, after a viral contamination event occurred, the drugmaker was not able to detect where the virus was entering the process.

Cleaning validation procedures for equipment also were found to be lacking, as there was no requirement to repeat cleaning or reevaluate it after initial cleaning. Inadequate cleaning procedures also were observed for equipment in fermentation and purification areas, and stains and mold were observed on the outside of tanks.

The 483 also cites Novo Nordisk for not establishing stability acceptance criteria for a master cell bank.

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