Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
The Food and Drug Administration inspected the Clayton, N.C., plant in July, and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.
The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
The Danish company said the Clayton plant is still running and producing for the market, and wouldn’t share details of its interactions with the FDA.
The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.
The company identified several strains of bacteria during the testing of semaglutide batches on at least three occasions between February and June, according to a partially redacted copy of the inspection report, dated July 13.
The FDA provided the report to The Journal in response to a public-records request.
The company conducted investigations of three bacteria events but as of July hadn’t been able to determine the source of the bacteria for two of the events, the report said. It described the company’s efforts to fix the problem as inadequate.
The inspection report is known as a Form 483, which the FDA issues when an inspector has observed a condition that might violate federal drug law, but it isn’t a final agency determination that a violation has occurred.
Companies receiving the reports are expected to take steps to address the issues and to document these steps to the FDA. Novo Nordisk said it has responded to the FDA’s observations.
Ozempic and Wegovy have been in short supply because Novo Nordisk can’t keep up with demand. The company has been seeking to add production capacity.
The Danish financial news agency MarketWire reported the existence of the FDA inspection report earlier this week.
Write to Peter Loftus at Peter.Loftus@wsj.com
