Novo Nordisk gets Form 483 from FDA after inspection at Plainsboro, NJ site

Following a Post-marketing Adverse Drug Experience (PADE) inspection at its Plainsboro, New Jersey site, Novo Nordisk announced on Tuesday that the U.S. Food and Drug Administration (FDA) has issued a Form 483 based on inspectional observations made by the agency on Feb. 7, 2025 at the facility.

Among the FDA’s observations, the regulator found that “not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.” The agency also observed that adverse drug experiences that were the subject of post marketing 15-day reports were not investigated. 

Among the safety events that went uninvestigated, were two deaths and one suicide. However, Novo Nordisk said that recent “untitled letters” for Ozempic and Wegovy are not related to this specific warning letter from the FDA and were in response to current advertising campaigns.

“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” Anna Windle, head of clinical development, medical and regulatory affairs for Novo Nordisk US, said in a statement. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”

Since the FDA inspection, the Danish drugmaker said it has been working to resolve the observations in the Form 483 through a corrective and preventative action plan and has kept the agency “informed on its progress, including through an initial response and seven updates.” Novo Nordisk said that it doesn’t expect the regulatory action to impact production.

At the same time, the company noted that over the past year it has “undertaken a broad, multi‑pronged effort to address the FDA PADE inspection — closing potential gaps while building durable and scalable pharmacovigilance capability.”

Other recent compliance challenges

This isn’t the only recent warning letter from the FDA. In late 2025, the agency issued a warning letter to Novo Nordisk regarding a former Catalent site in Bloomington, Indiana, which has been hit with regulatory actions. Among the current Good Manufacturing Practice (cGMP) violations, the agency’s warning letter called out Novo Nordisk’s inadequate investigations into drug product failures and discrepancies.

On Tuesday, Novo Nordisk said that it has “full confidence” that they “will be able to holistically and promptly address the matters outlined” in both warning letters related to the PADE inspection at the Plainsboro site and the second one related to the cGMP inspection at the Bloomington facility.

However, compliance problems at Novo Nordisk’s Bloomington plant have also negatively impacted its customers. 

Biopharma company Incyte received a Complete Response Letter (CRL) from the FDA recently for its supplemental Biologics License Application (sBLA) for monoclonal antibody Zynyz, citing inspection findings at Novo Nordisk’s Bloomington facility. Last year, Scholar Rock, received a CRL from the FDA for its Biologics License Application (BLA), resulting in the company’s spinal muscular atrophy candidate apitegromab being denied approval.

In 2025, the FDA published more than 200 CRLs issued in response to since-approved applications submitted to the agency for drugs and biological products. Pharma Manufacturing analyzed the published CRLs and out of a total of 202 decision letters issued between 2020 and 2024, 150 (74%) involved quality/manufacturing issues — including problems with manufacturing processes, facility inspections, or chemical, manufacturing and controls (CMC).

Several companies were hit with multiple CRLs over those years, including Alvotech, Azurity Pharmaceuticals, Celltrion, Coherus BioSciences, Dr. Reddy’s Laboratories, Eli Lilly, Pfizer, Sun Pharma, and Teva Pharmaceuticals.