# FDA 483 - Bausch Health US., LLC. - November 07, 2024

Source: https://www.globalkeysolutions.net/records/483/bausch-health-us-llc/3e4f42e1-1b96-426a-8138-68ddf864f234

> FDA 483 for Bausch Health US., LLC. on November 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch Health US., LLC.
- Inspection Date: 2024-11-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: During an inspection, Bausch Health US., LLC. was cited for failing to maintain adequate drug distribution and dispensing records for its approved REMS Implementation System. Specifically, the firm did not ensure that SILIQ was only distributed to certified pharmacies, as required by its REMS program. This indicates a significant lapse in oversight regarding restricted drug distribution.

## Related Documents

- [483 - 2021-06-16](https://www.globalkeysolutions.net/records/483/bausch-health-us-llc/11f7d9b5-bc0d-4053-b37a-85303478cd64)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jose-a-torres/0c491014-1dd0-4024-99b2-203b830b9c2b)
- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Meredith L. Miller](https://www.globalkeysolutions.net/people/meredith-l-miller/c775003b-4e5b-48d8-bc51-1a3ebe813dba)

Company: https://www.globalkeysolutions.net/companies/bausch-health-us-llc/67b95eb2-4614-4de7-a8ab-4b7f1b0cc331

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