# FDA 483 - Neurocrine Biosciences Inc - July 18, 2024

Source: https://www.globalkeysolutions.net/records/483/neurocrine-biosciences-inc/7ea6a782-f76f-4f79-b392-74ad4e8fa5b8

> FDA 483 for Neurocrine Biosciences Inc on July 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurocrine Biosciences Inc
- Inspection Date: 2024-07-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Neurocrine Biosciences Inc in San Diego, CA, revealed a significant deficiency in their postmarketing adverse drug experience surveillance. The firm failed to develop adequate written procedures for the receipt and evaluation of safety events, specifically regarding Huntington's Disease. This indicates a lack of robust pharmacovigilance processes.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)
- [Lan T. Tran](https://www.globalkeysolutions.net/people/lan-t-tran/ab9c1008-c03f-425f-ac3c-a569d3e5037c)

Company: https://www.globalkeysolutions.net/companies/neurocrine-biosciences-inc/581bbb4d-ebb5-4a84-8d2b-c877c8cc12c4

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6