CQRM BULLETIN - REPORTED CONTAMINATION IN SEMAGLUTIDE BATCHES
FDA Reports Novo Nordisk Detected Bacteria in Batches of Semaglutide
A recent FDA report finds that Novo Nordisk detected bacteria in batches of semaglutide.
Semaglutide is the primary component in its oral diabetes drug Rybelsus. The contamination was discovered at the Clayton, NC facility. Company officials said the semaglutide for its injected diabetes and weight loss drugs, Wegovy and Ozempic, is manufactured at other locations.
FDA officials carried out inspections of the Clayton site in July and released documents relaying that the company did not adequately look into the cause of contamination. The July FDA findings reveal that in tests of three semaglutide batches between February and June, Novo Nordisk staff found several strains of bacteria.
As of July, Novo Nordisk was unable to identify the source (s) of bacteria in two of the contaminations (according to FDA documentation, Form 483). The FDA also noted that the site's microbial controls were not sufficient.
The facility continues to operate. Manufacturing continues for the commercial market. The Form 483 indicates that the FDA has not yet made a determination of violation. Organizations that receive these forms are expected to resolve issues and file follow up with the agency.
Novo Nordisk states that they have followed up with the FDA regarding the inspection.