# FDA 483 - Indivior, Inc. - October 19, 2017

Source: https://www.globalkeysolutions.net/records/483/indivior-inc/ef9dbf71-9783-4e50-bcd9-71a3826dafa7

> FDA 483 for Indivior, Inc. on October 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indivior, Inc.
- Inspection Date: 2017-10-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Indivior Inc. in Richmond, VA, revealed a failure to ensure proper monitoring of clinical study RB-US-13-0001. Specifically, the firm did not adhere to its Oversight Monitoring Plan, leading to issues with essential document review, monitoring visit report review, and final unblinded monitoring visits. These deficiencies resulted in inadequate drug accountability and reconciliation at study sites.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.globalkeysolutions.net/companies/indivior-inc/538f0c04-f1ec-40f4-8d9f-90ffbe8c75ab

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e