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# Catalent Indiana Facility Cited in Form-483
- URL: https://www.fdaweb.com/catalent-indiana-facility-cited-in-form-483/
- Published: 2023-07-17T12:00:00.000Z
- Updated: 2026-09-14T18:44:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154886

FDA has issued Catalent a four-page[ Form FDA-483](https://www.fda.gov/media/170260/download?ref=fdaweb.com) after inspecting the firm’s Bloomington, IN 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 is inadequate, and equipment and facilities are not adequately maintained or cleaned.

Catalent is reportedly ([Bloomberg News](https://www.bloomberg.com/news/articles/2023-06-28/catalent-ctlt-linked-to-regeneron-regn-eye-drug-delay-in-latest-misstep?ref=fdaweb.com#xj4y7vzkg)) the third-party filler that Regeneron Pharmaceuticals said was responsible for a complete response letter (CRL) earlier this month on its BLA for aflibercept 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company [says](https://investor.regeneron.com/news-releases/news-release-details/fda-issues-complete-response-letter-crl-aflibercept-8-mg?ref=fdaweb.com) the issuance of the CRL was due solely to an ongoing review of inspection findings at the third-party filler.