# FDA 483 - Intercept Pharmaceuticals - February 01, 2016

Source: https://www.globalkeysolutions.net/records/483/intercept-pharmaceuticals/6170efbf-60f4-45a9-b373-63be5382379f

> FDA 483 for Intercept Pharmaceuticals on February 01, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intercept Pharmaceuticals
- Inspection Date: 2016-02-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Intercept Pharmaceuticals, Inc. in San Diego revealed significant deficiencies in clinical trial oversight. The firm failed to adequately monitor studies, retain essential records, and properly document the transfer of obligations to a contract research organization. These issues indicate a lack of robust controls over clinical trial conduct and data integrity.

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/intercept-pharmaceuticals/f9615f0e-eeca-417c-897e-a5611a7fd51c

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