# FDA 483 - Janssen Vaccines Corporation - November 19, 2024

Source: https://www.keypedia.com/records/483/janssen-vaccines-corporation/cc06717d-09af-4dd4-b4a3-5867912e7bf8

> FDA 483 for Janssen Vaccines Corporation on November 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Vaccines Corporation
- Inspection Date: 2024-11-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Janssen Vaccines Corporation in Incheon, Korea, revealed five significant observations concerning their drug product manufacturing operations. The firm failed to adhere to procedures for reporting product quality complaints and demonstrated deficiencies in aseptic processing controls, including unapproved interventions and inadequate operator behavior. Further issues included insufficient environmental monitoring, poor equipment design and cleanliness in aseptic areas, and inadequately qualified integrity testing equipment, collectively indicating a serious lack of control over sterile drug product quality.

## Related Documents

- [483 - 2022-03-02](https://www.keypedia.com/records/483/janssen-vaccines-corporation/da39d3e8-e72e-464d-a156-47bccd22295d)
- [483 - 2024-11-19](https://www.keypedia.com/records/483/janssen-vaccines-corporation/491410b1-aae8-4f81-8ace-87c3ff0279df)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/janssen-vaccines-corporation/37824380-beec-4bdd-8b7d-a8441dfb6991

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8