# FDA 483 - Novartis Pharmaceuticals Corporation - Unknown Date

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/c31e1262-2601-41e1-b055-114f96464537

> FDA 483 for Novartis Pharmaceuticals Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An inspection of Novartis Pharmaceuticals Corporation's gene therapy product manufacturing facility in Morris Plains, NJ, revealed significant deficiencies. The firm's process validation for CTL-019 manufacturing was incomplete, with issues noted in the process performance qualification study and un-evaluated changes to the commercial process. Additionally, the facility failed to initiate or investigate deviations for numerous microbial monitoring action level excursions.

## Related Documents

- [EIR - 2017-04-07](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/dc811ce0-15ca-4574-b458-2033e9d22993)
- [EIR - 2019-08-21](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/43fb0c26-6023-4fdb-a1bf-b32b89a06cda)
- [483 - 2019-08-21](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/46e237ea-aa74-4167-91ef-3f93ae6e17f4)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/b1680319-d6ed-404f-97d8-29d30a5966c6)
- [UNTITLED_LETTER - 2023-08-08](https://www.keypedia.com/records/untitled_letter/novartis-pharmaceuticals-corporation/cd26624a-3912-48a5-979f-444b80110332)

## Related Officers

- [Shoubai Dou](https://www.keypedia.com/people/shoubai-dou/fa9b58ec-fa18-4ec2-9553-72a7f703df05)
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Company: https://www.keypedia.com/companies/novartis-pharmaceuticals-corporation/21559fd5-35ed-4cbd-b228-623dd76bcf47

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