# FDA 483 - Bausch Health US., LLC. - June 16, 2021

Source: https://www.keypedia.com/records/483/bausch-health-us-llc/11f7d9b5-bc0d-4053-b37a-85303478cd64

> FDA 483 for Bausch Health US., LLC. on June 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch Health US., LLC.
- Inspection Date: 2021-06-16
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Bausch Health Companies, Inc. in Bridgewater, NJ, was inspected regarding its corporate office operations. The inspection revealed a significant issue with the firm's failure to maintain adequate drug distribution and dispensing records for SILIQ, specifically concerning its approved REMS Implementation System. This lapse resulted in the inability to ensure SILIQ was only distributed to certified pharmacies.

## Related Documents

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## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

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

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