# FDA 483 - Novartis Pharmaceuticals Corporation - January 24, 2017

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/4337d8c5-ec9f-4ec5-9878-9d9925dbaf1b

> FDA 483 for Novartis Pharmaceuticals Corporation on January 24, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2017-01-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novartis Pharmaceuticals Corp. in East Hanover, NJ, was cited for significant deficiencies in its conduct as a sponsor of clinical investigations. Observations included failures to notify the FDA of an investigator's termination, retain required records, adequately monitor study progress, and ensure studies adhered to protocols and investigational plans. These issues indicate systemic problems in clinical trial oversight.

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## Related Officers

- [investigator](https://www.keypedia.com/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)
- [Regulatory Officer](https://www.keypedia.com/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

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