# FDA EIR - Janssen Biotech, Inc. - November 30, 2018

Source: https://www.keypedia.com/records/eir/janssen-biotech-inc/bfbfb079-348c-422b-b82a-739f6507036f

> FDA EIR for Janssen Biotech, Inc. on November 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Janssen Biotech, Inc.
- Inspection Date: 2018-11-30
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA surveillance inspection of Janssen Research and Development, LLC, located in Spring House, PA, took place from November 26-30, 2018. This inspection was a high-priority review for a New Drug Application (NDA 212018) for erdafitinib, conducted under the Compliance Program Guidance Manual 7348.810 for Sponsors, Contract Research Organizations, and Monitors. While no formal Form FDA-483 (Inspectional Observations) was issued at the conclusion of the inspection, specific concerns were discussed with the company's management. The main issues identified included an initial failure to provide a comprehensive list of all Contract Research Organizations (CROs) involved in the study, leading to a request for an updated vendor list. Furthermore, deviations were noted in the adherence to study protocols concerning dose interruptions and subject withdrawals due to adverse events. One instance involved a subject continuing treatment despite a Grade 3 adverse event, conflicting with the dose modification plan, though it was documented as a protocol deviation. Another discontinuation based on an investigator's cumulative assessment of Grade 1 and 2 adverse events was deemed acceptable but underscored the need for clarity. The primary actions required were the submission of the complete CRO/vendor list and a renewed emphasis on stringent adherence to study protocols, particularly regarding adverse event management and dose modification strategies, to prevent similar deviations in the future.

## Related Documents

- [EIR - 2018-03-05](https://www.keypedia.com/records/eir/janssen-biotech-inc/f1208d95-d1d1-4c0a-926b-52d5130846e7)
- [483 - 2018-03-05](https://www.keypedia.com/records/483/janssen-biotech-inc/7bb1eae4-93cc-4e04-a24d-a92ba5419340)
- [483 - 2026-05-18](https://www.keypedia.com/records/483/janssen-biotech-inc/49d46fef-c43c-4edf-92a6-85e4dd41c6cb)
- [483 - 2025-07-29](https://www.keypedia.com/records/483/janssen-biotech-inc/91999c27-fff3-4a2e-af28-81a6a8053369)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anastasia-offordile/299aed81-16f8-413e-a318-2d7f741957da)
- [investigator](https://www.keypedia.com/people/yohann-loriot/39004f86-f86c-4cf5-a961-b35d4d12e6f1)
- [company_representative](https://www.keypedia.com/people/monica-williams/5d04141c-e56b-48a5-91b7-00b2ae979045)
- [investigator](https://www.keypedia.com/people/arlene-siefker-radtke/6ccebf9d-cf97-455c-b7a0-509a80210924)
- [company_representative](https://www.keypedia.com/people/peter-de-porre/6ecd9345-7c33-4157-a94e-467edd6481cf)

Company: https://www.keypedia.com/companies/janssen-biotech-inc/5374365d-a0df-4a87-ad3d-2714628d3e57

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