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An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout.
Novo Nordisk has some facility issues to address.
As first reported by STAT News,1 the company’s Bloomington, IN plant that was acquired as part of last year’s Catalent acquisition2 has received an FDA Form 483. This type of citation3,4 is typically given following an inspection that in the agency’s eyes, violates the Food Drug and Cosmetic (FD&C) Act, along with other related acts.
In this particular case, the Indiana manufacturer plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.5 These issues were found during the late-June to mid-July 2025 timeframe.
This manufacturing plant also houses Regeneron and Scholar Rock therapies.
“Your investigation failed to determine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches,” the official report6 obtained by STAT wrote. “The review of related deviations was limited to a one-year time frame, and no complaints were assessed. Although components were considered a potential root cause, no corrective or preventative actions were taken to address this. Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred. In addition, approximately 14 other deviations were opened as a result of a gap analysis conducted in response to this deviation.”
As far back as June 2022, multiple clients had raised complaints about “foreign matter” or “particles” found in lots that were produced at the site. Fast forwarding to the February 2024 and May 2025 timeframe, the plant logged around 10 work orders for “recurrent leaks and other failures” in a specific system.5 Some of those faced significant repair delays.
As alluded to previously, Catalent’s ownership officially changed hands December of last year, after Novo Holdings, Novo Nordisk’s parent company, agreed to acquire the CDMO in a $16.5 billion deal.2 These sites house fill-finish processes.
“We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,” Novo Nordisk president and CEO Lars Fruergaard Jorgensen commented at the time of the announcement. “The acquisition complements the significant investments we are already doing in active pharmaceutical ingredients facilities, and the sites will provide strategic flexibility to our existing supply network.”
In other Catalent news, the CDMO recently cited an “unexpected shift in demand from a large customer,” and will be laying off 350 employees from its Baltimore gene therapy plant.2
“Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases/disorders,” a Catalent spokesperson told Endpoints News. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”
References
1. Silverman E, Chen E. Major US Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, and Other Problems, FDA Finds.STAT News. August 21, 2025. Accessed August 25, 2025. https://www.statnews.com/pharmalot/2025/08/21/novo-nordisk-catalent-manufacturing-plant-inspection/
2. Saraceno N. Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant.Pharmaceutical Commerce. August 20, 2025. Accessed August 25, 2025. https://www.pharmaceuticalcommerce.com/view/catalent-to-lay-off-350-workers-baltimore-gene-therapy-plant
3. FDA Form 483 Frequently Asked Questions.FDA. January 9, 2020. Accessed August 25, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
4. Kansteiner F. Novo Plant Acquired in Catalent Buyout Faces Renewed FDA Scrutiny With Form 483: Stat.Fierce Pharma. August 22, 2025. Accessed August 25, 2025. https://www.fiercepharma.com/manufacturing/novo-plant-acquired-catalent-buyout-faces-renewed-fda-scrutiny-form-483-stat
5. Manalac T. Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds.BioSpace. August 22, 2025. Accessed August 25, 2025. https://www.biospace.com/fda/novo-acquired-catalent-plant-plagued-by-unresolved-pest-contamination-issues-fda-finds
6. Novo Facility Inspection Report.FDA. https://www.statnews.com/wp-content/uploads/2025/08/catalent-form-483-jul-2025.pdf
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