Sep 22, 2023

Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina production plant. The facility produces major drug ingredients like semaglutide, the molecule behind Novo’s oral diabetes drug Rybelsus.

After inspecting Novo’s Clayton facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

Specifically, the two-observation report suggested Novo failed to thoroughly investigate unexplained batch discrepancies and dropped the ball when it comes to microbial controls.

As for what those “discrepancies” were, the FDA said Novo on at least three separate occasions identified “objectionable organisms” during in-process testing of intermediate semaglutide.

In terms of controls, microbial limits “have not been established for in-process API material," in which microbes were discovered during the recovery phase, the FDA went on to say.

In an email to Fierce Pharma, a Novo Nordisk spokesperson said the company doesn’t share details publicly about specific interactions with the FDA, but she noted the Clayton site is “running and producing for the market.”

"The facility cited in this letter manufactures API for Rybelsus, not Ozempic or Wegovy," the spokesperson added.

On the heels of a $2.58-billion global manufacturing investment last December, Novo in March spent $6.8 million to scoop up 104 acres of adjacent land to its Clayton site.

"For Novo Nordisk's production facilities in Johnston County, these land purchases are to ensure North Carolina remains a prime location for future potential expansion plans to improve and increase production capacity," Chad Henry, Novo Nordisk's general manager of U.S. product supply, said at the time.

Novo Nordisk had no current plans to develop the purchased land, the company told Fierce Pharma this past spring.

Novo Nordisk began operations in Clayton in 1993 with a plant that formulates and fills cartridges and vials, assembles pen devices and packages and labels the products.

After several expansions of the 457,000-square-foot facility, which employs 1,000 people, Novo Nordisk built a $2 billion plant next door that went online in 2021. It employs 700 people and is the company’s first facility outside of Denmark to produce active pharmaceutical ingredients.

Editor's note: This article has been updated to specify that Novo Nordisk's Clayton, NC, facility produces drug ingredients for Rybelsus, not Ozempic and Wegovy.