# FDA 483 - Janssen Biologics B.V. - Unknown Date

Source: https://www.keypedia.com/records/483/janssen-biologics-bv/9559ba82-0b04-44ff-aefd-5c27de571195

> FDA 483 for Janssen Biologics B.V. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Biologics B.V.
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Janssen Biologics B.V. in Sassenheim, The Netherlands, identified a systemic failure in the firm's manufacturing operations. The company did not consistently adhere to its own established procedure for initiating investigations into nonconformances. This indicates a significant issue with procedural compliance within their quality system.

## Related Officers

- [Sharmila Shrestha](https://www.keypedia.com/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
- [investigator](https://www.keypedia.com/people/kevin-j-matthews/ee27a58a-3d45-4ac6-979f-7659067c11e6)
- [Jessica Spengler](https://www.keypedia.com/people/jessica-spengler/60c90d34-389c-4f26-933d-94acfb82809a)
- [Stephanie Val](https://www.keypedia.com/people/stephanie-val/d613dcbc-1449-4e6a-a34f-fe4f1e798f64)

Company: https://www.keypedia.com/companies/janssen-biologics-bv/7a6ebdd7-85cd-43b7-89e6-39accf2da352

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4