# FDA 483 - Novartis Pharmaceuticals Corporation - February 06, 2026

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/5f685210-dc63-45e1-8c77-efd089d4eafb

> FDA 483 for Novartis Pharmaceuticals Corporation on February 06, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2026-02-06
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: Novartis Pharmaceuticals Corporation in Morris Plains, NJ, a biological drug product manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate recurring foreign particulates in final product bags for CARVYKTI, lacked adequate procedures to prevent microbiological contamination for sterile products like CARVYKTI and KYMRIAH, and did not properly maintain equipment, leading to corrosion in manufacturing areas. These issues indicate a serious lack of control over manufacturing processes and environmental conditions.

## Related Documents

- [EIR - 2017-04-07](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/dc811ce0-15ca-4574-b458-2033e9d22993)
- [483 - Unknown Date](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/c31e1262-2601-41e1-b055-114f96464537)
- [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)

## Related Officers

- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Christian Lynch](https://www.keypedia.com/people/christian-lynch/ee342d8e-9fcf-4c84-9494-ceaf6320faf6)

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