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# FDA Releases Novo Nordisk FDA-483
- URL: https://www.fdaweb.com/fda-releases-novo-nordisk-fda-483/
- Published: 2023-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:57:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155395

FDA has released a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection. The document’s release comes on the heels of a 9/21 unusual agency statement provided to ***FDA Webview*** ([see story](https://www.fdaweb.com/fda-dismisses-novo-nordisk-inspection-concerns/)) discussing the inspection and a 2022 inspection at the same facility to quell concerns about any quality issues involving products made there, which include its diabetes and weight-loss drug semaglutide (trade names Ozembic and Wegovy).

According to the [just-released FDA-483](https://www.fda.gov/media/172377/download?ref=fdaweb.com), agency investigators said the facility failed to “thoroughly investigate the cause of any unexplained discrepancy.” Specifically, it said the firm identified objectionable organisms during in-process testing of intermediate semaglutide active pharmaceutical ingredient (API) on at least three occasions for batches manufactured in the recovery area between February and June.

The inspection report said that two associated deviation reports have been “ineffective in determining the source and corrective actions are inadequate.” It expressed further concern that additional batches of intermediate semaglutide API were also manufactured during this time frame.

Additionally, the second finding cited microbial controls that are deficient because microbial limits have not been established for in-process API material, which has had microbes identified during the recovery phase.