> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Novartis Not Penalized for Zolgensma Violations
- URL: https://www.fdaweb.com/novartis-not-penalized-for-zolgensma-violations/
- Published: 2020-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:09:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146460

FDA will not penalize Novartis for submitting manipulated test results tied to its Zolgensma gene therapy last year. *BioPharma Dive* [reports](https://www.biopharmadive.com/news/novartis-zolgensma-fda-data-review-form-483/575142/?ref=fdaweb.com) online that the violations were documents in an 8/2019 [inspection](http://fdaweb.com/login.php?sa=v&aid=D5145079&searchWords=Zolgensma&cate=S&stid=%241%243w3.Oh0.%2436Ctlv3zgtWrvnWsVN3Fx.&ref=fdaweb.com) of the company’s AveXis unit that led to the dismissal of two AveXis senior executives.

FDA had said it would consider civil or criminal penalties against Novartis because the company had been aware of the problem and proceeded to seek approval for Zolgensma, the report says.

In the end, according to *BioPharma Dive*, FDA classified the inspection review as “voluntary action indicated,” meaning that the violations found during the inspection didn’t cross the threshold for regulatory action.