# FDA 483 - Novartis Gene Therapies, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/novartis-gene-therapies-inc/7ee78b1e-35f2-4513-9edf-a537c4b21b9b

> FDA 483 for Novartis Gene Therapies, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Gene Therapies, Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: AveXis, Inc. in Libertyville, IL, was cited with 13 observations during an FDA inspection from February 4-8, 2019. The inspection revealed significant deficiencies in quality control, including failures to follow written procedures, inadequate corrective actions for recurring issues, and a lack of essential written procedures for critical manufacturing and labeling processes. Multiple instances of product control issues, such as incorrect labeling and conditional release without proper testing, were noted, alongside recurring mold contamination in cleanroom environments.

## Related Documents

- [483 - 2021-06-16](https://www.globalkeysolutions.net/records/483/novartis-gene-therapies-inc/9b49b78c-7eb5-4d4b-8c48-7f5739a303b9)

## Related Officers

- [Angela Whatley](https://www.globalkeysolutions.net/people/angela-whatley/80b1bb4a-5a95-471a-b78b-fbc2c0582d96)
- [investigator](https://www.globalkeysolutions.net/people/andrew-byro/7efb261b-2060-40a8-b3e3-779da167ab13)
- [Deborah Tross](https://www.globalkeysolutions.net/people/deborah-tross/4bb1492a-9845-411e-9fea-390feaad67c6)
- [investigator](https://www.globalkeysolutions.net/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)

Company: https://www.globalkeysolutions.net/companies/novartis-gene-therapies-inc/58c140f1-7389-4053-a757-b61650a3a86a

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd