FDA Found Bacterial Contamination at Novo Nordisk Diabetes Pill Manufacturing Facility

A sign for the Food and Drug Administration (FDA) outside of the headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)

Some batches of a diabetes drug manufactured by Novo Nordisk at a North Carolina plant were contaminated with bacteria, according to an inspection conducted by the U.S. Food and Drug Administration (FDA).

The bacteria were found in batches of semaglutide, the main ingredient for the company’s diabetic pill Rybelsus. The contamination was found in Novo Nordisk’s plant in Clayton, North Carolina, in July.

The FDA issued a Form 483 inspection report, stating that Novo Nordisk had failed to investigate the contamination cause and that microbial controls at the plant were insufficient, The Wall Street Journal reported.

According to the July 13 report, Novo Nordisk identified multiple strains of bacteria between February and June, at least three times, when testing semaglutide batches.

Though the Danish company investigated the events, it was not able to identify the source of bacteria for two of the three events. The FDA inspection report claimed that Novo Nordisk’s attempts to resolve the issues were insufficient.

Semaglutide is also the key ingredient in Novo Nordisk’s popular weight loss drugs Wegovy and Ozempic. However, the company clarified to The Wall Street Journal that the semaglutide used in these drugs is not manufactured at the Clayton plant.

The Clayton plant is still operational and producing medications for the market, the company said.

Form 483 is used by the FDA to notify a drug company of “objectionable conditions.” It is issued after an inspection when agency investigators identify conditions they deem to violate federal drug laws. However, the report itself is not a final FDA determination that a violation has taken place.

Companies that receive Form 483 are expected to address issues outlined in the report and document steps they have taken to the FDA.

In a statement to Bloomberg, the FDA said that it “does not have information that suggests ongoing compliance issues that raise concerns about the quality of drug products manufactured at the site.”

Even though the Clayton plant has been issued a Form 483, financial services company Jefferies does not expect the incident to disrupt supply.

“Stepping back, we’ve seen other Form 483s/warning letters raising concerns, including bacterial contamination. That said, they rarely prevented ongoing supply,” Jefferies said in a note, according to Bloomberg.

Stock Market Reaction, Quality Control

The FDA inspection at the Clayton plant was first reported by financial news agency MarketWire on Sept. 18, which triggered a decline in Novo Nordisk’s share prices.

The company’s shares have made a small recovery since hitting a low on Sept. 25. Year-to-date, Novo Nordisk shares are up over 37 percent as of 7:15 a.m. Eastern time on Tuesday.

An FDA report recently obtained by Reuters showed that the agency identified quality issues with Novo Nordisk’s Clayton plant as early as May 2022. Issues were related to the factory’s control systems to prevent microbial contamination, the same issue found by the FDA in July 2023.

The May 2022 report claimed that the Clayton plant failed to include a type of bacteria called B. cepacia in its list of “objectionable organisms.” Two investigations conducted by Novo Nordisk’s lab in 2020 and 2021 revealed the contamination of this bacteria, the report stated.

It also identified a second lapse at the plant—“failure to clean equipment at appropriate intervals” so as to prevent the buildup of microbes. The equipment was used for “continuous production” of semaglutide.

Speaking to Reuters, Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality, said that “it looks like (the factory) amped up their objectionable organism list, but now they aren’t adequately investigating issues when they identify one of the objectionable organisms.”

Semaglutide Concerns

Semaglutide was recently flagged by the European Medicines Agency (EMA) for potential thyroid cancer risk. The study that led to the EMA alert found an increased risk of thyroid cancer among individuals taking drugs like Ozempic and Wegovy, which include semaglutide as an active ingredient.

However, two commentaries on the study published in the Diabetes Care journal raised doubts about the validity of the findings.

In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles on April 17, 2023. (Mario Tama/Getty Images)

The FDA advises people with a family history of thyroid cancer or those with “hypersensitivity to semaglutide” against taking Wegovy. “In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures,” it said. However, the impact on humans remains unknown, the FDA stated.

Novo Nordisk’s semaglutide drugs Ozempic and Wegovy are used as weight loss medication, with some studies finding that they do aid in losing weight.

However, Health Canada, which is responsible for Canada’s national health policy, cited a 2020 study which found that nondiabetic people who took semaglutide ended up gaining much of their weight back within a year of stopping the medication.

Earlier in September, the family of a man who committed suicide after taking Ozempic blamed the medication for the tragedy. In a statement to The Epoch Times responding to the incident, Novo Nordisk insisted that semaglutide was safe for use.

“Safety data collected from large clinical trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts,” the company said.

There are also concerns about losing appetite when using semaglutide drugs. In an interview with Healthline, Dr. Daniel Maselli, an obesity medicine specialist, explained that as with all medications, semaglutide will affect people differently, with the drug’s effect varying along a spectrum.

“Semaglutide is no exception to this,“ Mr. Maselli said. ”At one extreme, we have very minimal effect on appetite at all, and on the other extreme, we have patients who have such an over-regulated appetite that they can lose both drive to eat and pleasure from eating significantly.”