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# FDA 483 Shows GMP Troubles at Plant Making Eylea
- URL: https://www.fdaweb.com/fda-483-shows-gmp-troubles-at-plant-making-eylea/
- Published: 2025-08-22T12:00:00.000Z
- Updated: 2026-09-14T15:19:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159743

Regeneron’s FDA delays in getting two regulatory submissions approved for Eylea HD (aflibercept) injection 8 mg are shedding light on the extent of problems being uncovered in agency inspections at the plant that manufactures the product. [Earlier this week](https://www.fdaweb.com/2-eylea-hd-submissions-get-review-extensions/), the company announced the delay in reviewing these because information submitted to address a recent inspection was deemed a major amendment. One submission was a chemistry, manufacturing and controls prior-approval supplement for the Eylea HD prefilled syringe, and the other was a supplemental BLA seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week (monthly) dosing across approved indications, according to the company.

A new 7/14 [inspection report](https://www.statnews.com/wp-content/uploads/2025/08/catalent-form-483-jul-2025.pdf?ref=fdaweb.com) obtained by *STAT News* reveals numerous GMP deficiencies at the manufacturing facility in Bloomington, IN — formerly owned by Catalent and now operated by Novo Nordisk. The facility serves as a fill-finish site for multiple pharmaceutical products, including Eylea HD. Findings include:

- Contamination Issues: The facility was cited for unresolved concerns, including the presence of cat hair, human hair in vial stoppers, bacterial contamination, and pests in classified areas. Investigators noted that root causes weren’t established, nor were the broader impacts on drug lots assessed.
- Equipment Failures: The plant reportedly had recurrent equipment failures, including leaks, that were not properly investigated or remedied in a timely manner.
- Testing and Controls Lapses: FDA also flagged inadequate environmental monitoring in aseptic areas and the facility's reliance on supplier testing for high-risk components (such as polysorbate 20 and 80) without conducting independent verification.

Regeneron emphasized that these manufacturing issues are unrelated to Eylea HD’s safety or efficacy profile. “Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA,” a Regeneron statement says. “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved.”

Last month, FDA released Catalent’s four-page[ Form FDA-483](https://www.fda.gov/media/170260/download?ref=fdaweb.com) that was issued after the agency inspected the manufacturing facility 5/4-12\. According to the inspection form, Catalent was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment revalidation was inadequate, and equipment and facilities were not adequately maintained or cleaned.

This is not the first time the Bloomington plant has had issues. In late 2023, the FDA delayed Regeneron’s high-dose Eylea approval by two months due to cleaning and procedural deficiencies at the same facility, then still under Catalent’s ownership.