# FDA EIR - Janssen Biotech, Inc - September 27, 2024

Source: https://www.keypedia.com/records/eir/janssen-biotech-inc/01f96702-1da6-4cec-a3d8-3d715cd9c06e

> FDA EIR for Janssen Biotech, Inc on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Janssen Biotech, Inc
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Janssen Biotech, Inc. in Titusville, NJ, underwent an FDA inspection from September 09 to September 27, 2024. The inspection primarily focused on the company's adherence to its Risk Evaluation and Mitigation Strategy (REMS) program, which is designed to ensure the safe use of its products through rigorous oversight of healthcare provider and pharmacy certification, enrollment processes, and dispensing protocols. While the review of specific prescriber and pharmacy enrollment forms and their associated processes did not reveal direct deficiencies, a general observation was identified during the REMS segment of the inspection. The main issue noted was "The lack of clearly defined timelines allocated to each audit activity in the firm’s audit plan." In response to this finding, Janssen Biotech management committed to internally assess the situation and develop appropriate remedial actions. The company is required to submit a formal response to the FDA within 15 business days. The inspection concluded with the issuance of a Form FDA-483, Inspectional Observations, indicating the need for corrective measures to enhance the clarity of timelines within their audit plan under the REMS framework.

## Related Documents

- [483 - 2024-09-27](https://www.keypedia.com/records/483/janssen-biotech-inc/fa919dc3-c851-457d-bfe2-005bbbfc5b72)
- [483 - 2024-09-27](https://www.keypedia.com/records/483/janssen-biotech-inc/b0f75aa3-e5bb-4f56-ba6c-c8f44f8c2da1)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/janssen-biotech-inc/0e596905-d650-4a96-a491-6ff9467cafbf)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/janssen-biotech-inc/7d87f794-c8cc-4a2c-b985-4d62ebc2d60b

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c