# FDA 483 - Sanofi US - August 03, 2016

Source: https://www.keypedia.com/records/483/sanofi-us/2ee0b9b4-3a65-45a0-8663-a8eea17af086

> FDA 483 for Sanofi US on August 03, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi US
- Inspection Date: 2016-08-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Sanofi US in Bridgewater, NJ was inspected from July 25 to August 3, 2016. The inspection revealed one observation related to postmarketing reporting. Specifically, the firm failed to include copies of published scientific articles with 15-day Alert reports.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [investigator](https://www.keypedia.com/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)
- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/sanofi-us/83318d37-cfae-4026-9eb2-9cf8a513d61e

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