# FDA 483 - FOAMIX PHARMACEUTICALS, INC. - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/foamix-pharmaceuticals-inc/cb497273-e221-4669-b61e-93757721f2c3

> FDA 483 for FOAMIX PHARMACEUTICALS, INC. on April 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FOAMIX PHARMACEUTICALS, INC.
- Inspection Date: 2019-04-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of FORMIX PHARMACEUTICALS, INC. in Bridgewater, NJ, revealed significant deficiencies in the conduct and oversight of clinical trials. The firm failed to ensure proper monitoring of studies, leading to undetected serious adverse events and non-compliance with protocol requirements. Additionally, unqualified investigators were selected for a drug study, violating selection criteria.

## Related Officers

- [Shirley S. Wen](https://www.globalkeysolutions.net/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.globalkeysolutions.net/companies/foamix-pharmaceuticals-inc/9912add0-b999-40e7-9fe5-60ded461ff2c

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