# 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

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- [UNTITLED_LETTER - 2023-08-08](https://www.keypedia.com/records/untitled_letter/novartis-pharmaceuticals-corporation/cd26624a-3912-48a5-979f-444b80110332)
- [483 - 2024-08-08](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/44e0cb23-0ec8-4334-bb8c-6f66a38965a7)

## Related Officers

- [Douglas Davis](https://www.keypedia.com/people/douglas-davis/04ad04d8-bc13-4a5b-8f7c-7e6ed03f3d42)
- [Bojan Melekov](https://www.keypedia.com/people/bojan-melekov/2d7b5c6c-7d6a-43c1-8d82-4b51dd71d7b9)
- [Juan Johnson](https://www.keypedia.com/people/juan-johnson/ace8a736-9e01-4172-80ec-10aec17ea26a)
- [Ashley J. Burns](https://www.keypedia.com/people/ashley-j-burns/c4344aad-6456-4e9f-b992-09941b734fe6)
- [Peter J. Abb](https://www.keypedia.com/people/peter-j-abb/d1840ef8-d6aa-4bd7-8fb4-14d0a3a0c762)

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