# FDA 483 - Janssen Pharmaceuticals Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/janssen-pharmaceuticals-inc/82d909e3-7138-4083-bfb4-4a18fd99a0de

> FDA 483 for Janssen Pharmaceuticals Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Pharmaceuticals Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Janssen Biopharmaceuticals, Inc. in Raritan, NJ, a lentiviral vector manufacturer, identified two significant observations. The firm was cited for deficient control and maintenance of manufacturing systems, evidenced by numerous events on a manufacturing line. Additionally, investigations into deviations were not initiated in a timely manner, with multiple nonconformance reports exceeding required creation timelines.

## Related Documents

- [483 - 2023-12-14](https://www.keypedia.com/records/483/janssen-pharmaceuticals-inc/c421012f-38e2-4ef0-8f9f-cd8d3bea7155)

## Related Officers

- [Lead Consumer Safety Officer](https://www.keypedia.com/people/xiuju-lu/90517f8a-e5ac-44a9-b2a2-3358e114754f)
- [Carl A. Perez](https://www.keypedia.com/people/carl-a-perez/a7214b90-7632-4aff-8afb-33f1d7e7917d)
- [investigator](https://www.keypedia.com/people/kevin-j-matthews/ee27a58a-3d45-4ac6-979f-7659067c11e6)

Company: https://www.keypedia.com/companies/janssen-pharmaceuticals-inc/b494dc6e-cfeb-46a2-8c10-e036e6a5a623

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd