# FDA 483 - Novartis Pharmaceuticals Corporation - July 02, 2019

Source: https://www.globalkeysolutions.net/records/483/novartis-pharmaceuticals-corporation/674462be-82ec-4826-9df2-f767c3094372

> FDA 483 for Novartis Pharmaceuticals Corporation on July 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2019-07-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: During an inspection from June 19 to July 2, 2019, Novartis Pharmaceuticals Corporation in East Hanover, NJ, was cited for failing to ensure a clinical study was conducted in accordance with its protocol and standard operating procedures. The firm did not provide necessary documentation to demonstrate that user acceptance testing for an Interactive Response Technology (IRT) system, critical for trial activities, was properly approved and signed. This indicates a significant deficiency in record-keeping and adherence to trial conduct requirements.

## Related Officers

- [Shirley S. Wen](https://www.globalkeysolutions.net/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)
- [investigator](https://www.globalkeysolutions.net/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)

Company: https://www.globalkeysolutions.net/companies/novartis-pharmaceuticals-corporation/5d9b7200-60f5-4803-80b8-0af1ba4f161c

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