# FDA 483 - PRACS Institute, Ltd. - August 06, 2012

Source: https://www.globalkeysolutions.net/records/483/pracs-institute-ltd/be726d70-9c2e-4c51-bb16-5d892c61568d

> FDA 483 for PRACS Institute, Ltd. on August 06, 2012. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PRACS Institute, Ltd.
- Inspection Date: 2012-08-06
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of PRACS Institute, Ltd., a Contract Research Organization in Fargo, ND, revealed a significant failure to address and resolve issues concerning study samples for a specific study. This observation indicates potential deficiencies in the firm's quality control or data management processes.

## Related Officers

- [Pharmacologist at FDA](https://www.globalkeysolutions.net/people/xikui-chen/b320acb8-c976-4b42-bfdb-95b1701e7627)
- [Darren D. Holaday](https://www.globalkeysolutions.net/people/darren-d-holaday/30fa4f62-825f-4dfd-a7a3-0c08c20b93c4)

Company: https://www.globalkeysolutions.net/companies/pracs-institute-ltd/4ddea77d-ad5a-41d6-83c6-7abe4e49efb4

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d