# FDA 483 - Corcept Therapeutics Incorporated - May 09, 2014

Source: https://www.keypedia.com/records/483/corcept-therapeutics-incorporated/e29fa5e1-8f62-47d4-8233-2c983ef5b68f

> FDA 483 for Corcept Therapeutics Incorporated on May 09, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corcept Therapeutics Incorporated
- Inspection Date: 2014-05-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Co-Cept Therapeutics Incorporated, a sponsor, was inspected from May 5-9, 2014, revealing significant deficiencies in their postmarketing adverse drug experience reporting system. The firm lacked comprehensive written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences to the FDA. This included inadequate oversight of outsourced pharmacovigilance vendors and a failure to establish procedures for NDA Field Alert Reports.

## Related Officers

- [Anh M. Lac](https://www.keypedia.com/people/anh-m-lac/20a897c2-ad8c-4bea-8060-34ba80d64d1e)

Company: https://www.keypedia.com/companies/corcept-therapeutics-incorporated/9f3284cd-b285-4408-818e-19b78043d2e3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b