# FDA 483 - Braeburn Pharmaceuticals Inc. - February 08, 2018

Source: https://www.globalkeysolutions.net/records/483/braeburn-pharmaceuticals-inc/b34a34bc-dfd5-4297-9b5a-0f7eeefe5cb5

> FDA 483 for Braeburn Pharmaceuticals Inc. on February 08, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Braeburn Pharmaceuticals Inc.
- Inspection Date: 2018-02-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Braeburn Pharmaceuticals Inc.'s corporate office in Princeton, NJ, revealed two significant issues. The firm failed to report serious and unexpected adverse drug experiences within the required 15-day timeframe. Additionally, Braeburn Pharmaceuticals did not adhere to the audit plan and schedule outlined in its approved REMS Implementation System for Probuphine inserters.

## Related Officers

- [Michelle A Marsh](https://www.globalkeysolutions.net/people/michelle-a-marsh/0aef2015-621a-4948-bb7e-2be3e338a8c8)
- [Shirley S. Wen](https://www.globalkeysolutions.net/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.globalkeysolutions.net/companies/braeburn-pharmaceuticals-inc/9e6d4a27-2411-4059-a693-b9e3e42d3022

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