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# Novo Nordisk Gets FDA-483: Reports
- URL: https://www.fdaweb.com/novo-nordisk-gets-fda-483-reports/
- Published: 2023-09-18T12:00:00.000Z
- Updated: 2026-09-14T18:56:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155353

FDA has reportedly issued Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a key facility for making its diabetes and weight-loss drug semaglutide (trade names Ozembic and Wegovy). The agency action was reported by *Marketwire News* and picked up by [Reuters](https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-shares-fall-after-media-report-about-quality-lapses-us-plant-2023-09-18/?ref=fdaweb.com) and other media outlets. At press time, FDA had not posted any information about the inspection, and Novo Nordisk declined comment other than saying the facility was “running and producing for the market.” There has been increased demand for Ozembic and Wegovy, and FDA’s drug shortage list has [several Wegovy dosages](https://www.accessdata.fda.gov/scripts/drugshortages/dsp%5FActiveIngredientDetails.cfm?AI=Semaglutide%20Injection,%20Solution&st=c&ref=fdaweb.com) and one Ozempic dosage shown.