# FDA 483 - AMARIN PHARMACEUTICALS, INC - June 04, 2001

Source: https://www.keypedia.com/records/483/amarin-pharmaceuticals-inc/cdb13607-5ea0-41ca-aa68-bbeac0d0f363

> FDA 483 for AMARIN PHARMACEUTICALS, INC on June 04, 2001. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMARIN PHARMACEUTICALS, INC
- Inspection Date: 2001-06-04
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Amarin Pharmaceuticals, Inc. in Warren, NJ on June 4, 2001, identified one observation. The firm was cited for an inadequate written procedure regarding the surveillance, receipt, evaluation, and reporting of adverse drug experiences. This indicates a deficiency in their pharmacovigilance processes.

## Related Officers

- [Byungja E. Marciante](https://www.keypedia.com/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)

Company: https://www.keypedia.com/companies/amarin-pharmaceuticals-inc/1f134102-a432-4b0f-9286-17d42c4becb2

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