# FDA 483 - Novartis Gene Therapies Inc. - January 26, 2024

Source: https://www.keypedia.com/records/483/novartis-gene-therapies-inc/396fb8e8-b277-46a7-9236-e075779c479a

> FDA 483 for Novartis Gene Therapies Inc. on January 26, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Gene Therapies Inc.
- Inspection Date: 2024-01-26
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Novartis Gene Therapies Inc. in Durham, NC, was inspected and cited for two observations related to its licensed biological drug product manufacturing. The firm failed to report a biological product deviation within the required 45-day timeframe for ZOLGENSMA Drug Product. Additionally, laboratory investigations into out-of-specification results for ZOLGENSMA Drug Substance were not adequately extended to other associated drug product and drug substance lots.

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/novartis-gene-therapies-inc/23cc49c0-8794-437d-a2c2-4197479c5fb3

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7