A Novo Nordisk plant in Denmark has received a warning letter from U.S. drug inspectors, which indicates that injectable drugs manufactured at the facility may be at risk of contamination.
The FDA warning letter was released this week, highlighting serious quality control concerns at the plant that could lead to contaminated drugs. The FDA also warned that Novo Nordisk had failed to properly investigate whether a failed batch of an unidentified drug had been distributed to the public.
At the Novo Nordisk plant, the FDA noted that a batch of an unidentified drug was found to contain too many impurities. The company responded by saying it was due to residue from one drug adhering to equipment that was also used by another. However, the FDA said the company did not launch an investigation until the problem was brought to Novo Nordisk’s attention by an FDA inspector.
The letter also included concerns that the company’s workers failed to collect about 846 environmental monitoring (EM) samples that are a crucial part of making sure that sterile drugs are actually sterile and not being contaminated. The failures occurred between March 2010 and February 2012.
“The substantial number of missed samples suggests a pattern that raises concerns regarding your environmental program,” the warning letter states. “Collecting scheduled EM samples is a critical aspect of any environmental control program at an aseptic manufacturing facility.”
The letter also cites the company for goggles worn by workers operating inside the sterile area of the plant that are not sterilized, but only sanitized. It also complained that the goggles have openings in them which could threaten the sterility of the area.