FDA regulatory actions regarding Novo Nordisk site result in CRL for Incyte

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to biopharma company Incyte for its supplemental Biologics License Application (sBLA) for monoclonal antibody Zynyz, citing inspection findings at Novo Nordisk’s third-party fill-finish facility, according to Incyte’s filing with the Securities and Exchange Commission.

“The CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC (Catalent Indiana), part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA,” Incyte reported.

Novo Nordisk bought the troubled Bloomington, Indiana facility — along with two other Catalent sites in Belgium and Italy — in an $11 billion deal completed in December 2024 with parent company Novo Holdings, which acquired the contract manufacturer for $16.5 billion.

In November 2025, a warning letter was issued to Novo Nordisk regarding the former Catalent site in Bloomington. Among the current Good Manufacturing Practice (cGMP) violations, the FDA’s warning letter — based on the regulator’s inspection of the Bloomington facility from June 23 to July 14, 2025 — called out Novo Nordisk’s inadequate investigations into drug product failures and discrepancies.

In the warning letter issued to Novo Nordisk, the FDA cited deviations at the site beginning in August 2023 — when it was still owned by Catalent — related to “extrinsic mammalian hair” contamination “in or around the stopper region of vials” and “including in direct contact with the drug product.” 

A Novo Nordisk spokesperson in an emailed statement to Pharma Manufacturing confirmed the drugmaker received an FDA warning letter following an inspection of its Bloomington site and that it is “actively engaging” with the agency to address its findings.

“At Novo Nordisk, we place great importance on quality and patient safety in all that we do,” the company spokesperson said. “Across our global operations, we strive for high-quality standards, supported by systems designed to ensure our products are safe and readily available for the patients who rely on them.”

The spokesperson said that Novo Nordisk remains “committed to continuous improvement through constructive dialogues and interactions with regulators and the broader industry,” adding that “when issues arise, we work responsibly to address findings, with patient safety and compliance as our primary priorities.”

Regarding its sBLA for Zynyz, Incyte’s filing states that the FDA’s CRL “cited the regulatory compliance of Catalent Indiana as the sole approvability issue” and “did not cite other approvability concerns.” Incyte said it is “working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission.”

Other companies impacted by problems at site

Compliance problems at Novo Nordisk’s Bloomington plant have also negatively affected Regeneron and Scholar Rock. 

In August 2025, the FDA pushed back its target decision date for two of Regeneron’s sBLAs for a high-dose formulation of Eylea, following the agency’s site inspection at the Novo Nordisk site in Indiana. In response, Regeneron said it planned to submit an application to the regulator to include an additional manufacturing filler.

In September 2025, Scholar Rock announced that the FDA issued a CRL for its Biologics License Application (BLA), which resulted in the company’s spinal muscular atrophy candidate apitegromab being denied approval.

At the time, CEO David Hallal in a statement said Scholar Rock is “continuing to work closely with Catalent Indiana on the FDA’s manufacturing observations so that we can resubmit the apitegromab BLA as soon as possible.”

History of compliance problems at site

In its own recent statements, Catalent has pointed out that as of December 2024 the Bloomington site is no longer part of Catalent’s network and is fully owned and operated by Novo Nordisk.

“Despite having announced and confirmed the ownership change, some recent reports continue to reference the Bloomington facility as part of Catalent’s network,” the company said. “These references are inaccurate and outdated. While legacy naming conventions such as ‘Catalent Indiana’ or ‘Catalent Indiana, LLC’ may still appear in certain regulatory filings, Catalent has no ownership, operational involvement, or oversight of the site.”

Nonetheless, compliance problems arose under Catalent’s previous ownership of the site.

In early 2024, Reuters obtained an FDA report in a Freedom of Information Act request, revealing that the Indiana plant recorded around 194 deviations between Oct. 31, 2021, and Oct. 31, 2023, “meaning some aspects of certain batches had failed to meet quality control standards” with Catalent failing to “identify the root cause of 171 of those incidents.”

Regulators in November 2023 found “quality control lapses” at the Indiana factory including discovery of a “pest” on the manufacturing line — though what sort of creature was found and precisely where was not explained in the FDA’s redacted report — according to Reuters.