# FDA EIR - Incyte Corporation - November 15, 2021

Source: https://www.keypedia.com/records/eir/incyte-corporation/85295354-a4c4-4df8-bd2e-4d824812028a

> FDA EIR for Incyte Corporation on November 15, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Incyte Corporation
- Inspection Date: 2021-11-15
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The Food and Drug Administration (FDA) conducted a PDUFA surveillance inspection of Incyte Corporation, a corporate headquarters and sponsor of clinical trials, from November 8 to November 15, 2021. This inspection, conducted under Compliance Program 7348.810 for Sponsors and Contract Research Organizations, evaluated three clinical studies submitted to the FDA under a New Drug Application. The review encompassed various aspects of the clinical trials, including adherence to sponsor requirements for ClinicalTrials.gov listings, site training and monitoring, safety monitoring, investigational product control, and financial disclosures. The qualifications of clinical site monitors, Independent Data Monitoring Committee (IDMC) communications, and contracts with Contract Research Organizations (CROs) were also assessed. Crucially, the FDA inspection concluded without any findings. No Form FDA 483, indicating objectionable conditions, was issued, and no discussion items were raised with management at the closeout meeting. The inspection report noted positive comments regarding the company's efficient and organized provision of requested records. Furthermore, Incyte Corporation had successfully addressed all four discussion items from a previous FDA inspection conducted in April 2021. Overall, the company demonstrated adequate oversight of its clinical studies and monitoring activities, with no non-compliant sites or under-reporting of serious adverse events.

## Related Officers

- [recipient](https://www.keypedia.com/people/michael-morrissey/36769d1a-1990-43bb-9836-325824d0d73c)
- [company_representative](https://www.keypedia.com/people/gaafer-el-mallah/46b3a828-77e0-4000-b717-88996b20174e)
- [company_representative](https://www.keypedia.com/people/michele-houghton/4c7fe1ee-4190-4ca4-9f3a-889ac995f84a)
- [company_representative](https://www.keypedia.com/people/peter-oneill/508ff71a-20f5-4739-8367-e0bfdc3c4a4e)
- [company_representative](https://www.keypedia.com/people/judith-presser/5a0f251d-4704-4021-8205-9cf0034d1a14)

Company: https://www.keypedia.com/companies/incyte-corporation/2f3187b3-71fc-4c7d-95bf-d829cc4eceec

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8