# FDA 483 - Janssen Vaccines Corporation - March 02, 2022

Source: https://www.keypedia.com/records/483/janssen-vaccines-corporation/da39d3e8-e72e-464d-a156-47bccd22295d

> FDA 483 for Janssen Vaccines Corporation on March 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Vaccines Corporation
- Inspection Date: 2022-03-02
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Janssen Vaccines Corp. in Yeonsu-gu, Incheon, Republic of Korea, was inspected from March 2-10, 2022, and received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, equipment validation and qualification, and laboratory controls. These issues indicate a high risk of microbiological contamination and product quality issues for sterile drug products.

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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Melissa D. Ray](https://www.keypedia.com/people/melissa-d-ray/d3edab82-132c-4a8f-997a-19d610a4f03a)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321