# FDA 483 - Novartis Pharmaceuticals Corporation - August 08, 2024

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/44e0cb23-0ec8-4334-bb8c-6f66a38965a7

> FDA 483 for Novartis Pharmaceuticals Corporation on August 08, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2024-08-08
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: Novartis Pharmaceuticals Corporation in Morris Plains, NJ, was cited for significant deficiencies in its manufacturing processes for sterile drug products, particularly Kymriah®. The inspection revealed issues with microbiological contamination prevention, inadequate laboratory controls for foreign particulates, and failures in quality control unit procedures regarding change control and batch record review. Additionally, the firm lacked appropriate computer system controls, indicating a broad range of compliance concerns.

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- [UNTITLED_LETTER - 2023-08-08](https://www.keypedia.com/records/untitled_letter/novartis-pharmaceuticals-corporation/cd26624a-3912-48a5-979f-444b80110332)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/novartis-pharmaceuticals-corporation/21559fd5-35ed-4cbd-b228-623dd76bcf47

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248