# Novartis Pharmaceuticals Corporation – FDA 483, Aug 21, 2023

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/b86a870b-4f00-4ca2-a2ea-f19029e24813

> FDA 483 for Novartis Pharmaceuticals Corporation on August 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2023-08-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Novartis Pharmaceuticals Corp. in East Hanover, NJ, revealed a failure to ensure proper monitoring of a clinical study. Specifically, investigational product was not stored at the required temperature and was dispensed to subjects, with monitoring visits failing to identify these temperature excursions. This indicates a critical lapse in clinical trial oversight and product integrity.

## Related Documents

- [483 - 2018-12-14](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/fbb8db5f-8a5a-4601-9915-315db47dee65) — date: December 14, 2018
- [EIR - 2017-09-07](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/faf8091c-3829-4500-a76d-e0a68515ed42) — date: September 7, 2017
- [EIR - 2017-03-02](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/4b8966de-a19c-48ea-91fb-d06761d6856a) — date: March 2, 2017
- [EIR - 2017-01-24](https://www.keypedia.com/records/eir/novartis-pharmaceuticals-corporation/f6b0814a-9c3b-48e4-a46d-b85c65a0df9e) — date: January 24, 2017
- [483 - 2017-01-24](https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/4337d8c5-ec9f-4ec5-9878-9d9925dbaf1b) — date: January 24, 2017

## Related Officers

- [Mayar M. Mussa](https://www.keypedia.com/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)
- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/novartis-pharmaceuticals-corporation/aa4c85c1-794a-407a-8eb3-8802c196795b

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