# FDA 483 - Novartis Gene Therapies, Inc. - June 16, 2021

Source: https://www.globalkeysolutions.net/records/483/novartis-gene-therapies-inc/9b49b78c-7eb5-4d4b-8c48-7f5739a303b9

> FDA 483 for Novartis Gene Therapies, Inc. on June 16, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Gene Therapies, Inc.
- Inspection Date: 2021-06-16
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: Novartis Gene Therapies, Inc. in Libertyville, IL, received a Form 483 with five observations during an FDA inspection of its gene therapy manufacturing facility. The inspection revealed significant deficiencies in laboratory controls, including inadequate procedures for OOS/OOT investigations, trending invalid analytical tests, and identifying Out of Expectation results. Additionally, the firm failed to retain reserve samples for drug products, lacked appropriate specifications for component quality, and had incomplete laboratory records.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/novartis-gene-therapies-inc/7ee78b1e-35f2-4513-9edf-a537c4b21b9b)

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)
- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.globalkeysolutions.net/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)

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

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669