# FDA 483 - Rho, Inc. - June 30, 2017

Source: https://www.globalkeysolutions.net/records/483/rho-inc/78a0906f-65e8-49bf-8a18-7a1e14020908

> FDA 483 for Rho, Inc. on June 30, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rho, Inc.
- Inspection Date: 2017-06-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Rho, Inc., a Contract Research Organization in Chapel Hill, NC, received a Form 483 following an inspection from June 26-30, 2017. The inspection revealed a failure to ensure investigations were conducted according to the investigational plan and IND protocols. This led to issues with subject randomization and the supply management of investigational products at clinical sites.

## Related Documents

- [EIR - 2017-06-30](https://www.globalkeysolutions.net/records/eir/rho-inc/d868f848-75f6-4e66-aeac-c084600b9566)

## Related Officers

- [other](https://www.globalkeysolutions.net/people/jean-mulinde/aa3050c6-5cf4-45b6-bac3-43c6c70edd09)
- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.globalkeysolutions.net/companies/rho-inc/adb4b7fe-7ba6-4c90-b87b-8642e6618910

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