# FDA 483 - Novartis Pharmaceuticals Corporation - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/novartis-pharmaceuticals-corporation/b1680319-d6ed-404f-97d8-29d30a5966c6

> FDA 483 for Novartis Pharmaceuticals Corporation on December 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2022-12-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novartis Pharmaceuticals Corporation in Morris Plains, NJ, was cited for significant deficiencies during an inspection related to the manufacturing of Kymriah product. Observations included recurring mold contamination in aseptic processing areas, continued use of primary packaging with foreign particulate matter, and unapproved manufacturing procedures. The firm also failed to adequately qualify equipment, maintain proper cleaning procedures, and conduct thorough investigations for out-of-trend results and process deviations.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

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

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