# FDA 483 - Novartis Pharmaceuticals Corporation - December 14, 2018

Source: https://www.keypedia.com/records/483/novartis-pharmaceuticals-corporation/fbb8db5f-8a5a-4601-9915-315db47dee65

> FDA 483 for Novartis Pharmaceuticals Corporation on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharmaceuticals Corporation
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Novartis Pharmaceuticals Corp. in East Hanover, NJ, was cited for significant failures in monitoring a clinical study. The firm failed to ensure the study was conducted according to the protocol and investigational plan, leading to numerous instances of site personnel and raters having inappropriate access to unblinded study subject information. Monitors also failed to identify and correct these critical database access errors over an extended period.

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## Related Officers

- [Kara Ayalew](https://www.keypedia.com/people/kara-ayalew/448bf470-6082-4f38-8314-87f670677fd2)
- [Regulatory Officer](https://www.keypedia.com/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)
- [investigator](https://www.keypedia.com/people/cheryl-a-grandinetti/db17fca7-6b39-48b9-a7f3-86817b56a9a1)

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