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# Catalent Hit With 12-item 483 on Moderna Vaccine
- URL: https://www.fdaweb.com/catalent-hit-with-12-item-483-on-moderna-vaccine/
- Published: 2022-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:00:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152790

FDA has issued contract manufacturer Catalent a [12-item Form FDA-483](https://www.fda.gov/media/161643/download?ref=fdaweb.com) over GMP concerns found during a recent inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-19 Bivalent booster vaccine.

The inspection concluded 9/2 and it is intended to add Catalent to Moderna’s emergency use authorization to increase distribution of the booster, according to a [9/20 FDA memo](https://www.fda.gov/media/161738/download?ref=fdaweb.com) discussing its evaluation. Due to concerns about potential supply limitations, Moderna requested that, in the interim, FDA review and authorize 10 certain batches of the final product produced at the Catalent facility. After reviewing the request, the agency said Moderna “provided sufficient data and information for FDA to determine that these batches are suitable for use and that their known and potential benefits outweigh their known and potential risks for the use… FDA does not intend to determine whether to add Catalent as an authorized manufacturing facility for the Moderna Covid-19 Vaccine, Bivalent until the agency’s evaluation of the inspection is complete.”

According to the inspection report, Catalent was cited for failing to investigate unexplained discrepancies, and to include findings and follow-up actions in its written complaint investigations. Additionally, the inspection found that the firm lacks control procedures to monitor output and validate the performance of those manufacturing processes that may be responsible for variability, among other violations.