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# Moderna Inspection Cites GMP Issues: Report
- URL: https://www.fdaweb.com/moderna-inspection-cites-gmp-issues-report/
- Published: 2023-12-17T12:00:00.000Z
- Updated: 2026-09-14T14:18:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156010

FDA investigators cited GMP issues during a September inspection at Moderna’s primary facility in Norwood, MA, according to a [Reuters report](https://kfgo.com/2023/12/15/exclusive-us-fda-finds-control-lapses-at-moderna-manufacturing-plant/?ref=fdaweb.com) based on a related Form FDA-483 the news service obtained under a Freedom of Information Act request. The 9/11-21 inspection of the facility that makes the company’s Covid-19 shot Spikevax and an experimental mRNA cancer vaccine under development with Merck cited five observations, including that the company had released eight batches of drug substance that were made equipment that had failed cleaning verification tests.

Moderna said in a statement provided to Reuters: “Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators.” It described the inspection as routine and said the findings do not reflect any product quality or safety concerns, adding that all product released by the company was tested and met product specifications.

The agency also cited Moderna over its procedures to ensure expired materials were not used to make vaccines and that airborne contaminants did not make it into any products. “Inspectors found more than 2,000 expired items in Moderna’s warehouse and cold storage not held in a separate or defined location from other materials,” Reuters said.

To date, FDA has not recorded any recalls related to the inspection.