# FDA 483 - Henogen SRL - November 22, 2024

Source: https://www.keypedia.com/records/483/henogen-srl/53cee9cf-582a-4b5b-9e20-8b6807483f93

> FDA 483 for Henogen SRL on November 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Henogen SRL
- Inspection Date: 2024-11-22
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, was inspected by the FDA, revealing a significant issue with the control data for manufacturing viral vectors. Specifically, the firm's batch records lacked adequate reconciliation of production yield and criteria for investigating yield deviations. This indicates a moderate severity issue related to quality control and data integrity in their manufacturing processes.

## Related Documents

- [483 - 2024-11-22](https://www.keypedia.com/records/483/henogen-srl/2b8c2510-c4d6-4ff8-995d-f8e56407bf37)
- [483 - 2024-11-22](https://www.keypedia.com/records/483/henogen-srl/bd6917a3-8a73-477f-a83f-c6e982101046)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)

Company: https://www.keypedia.com/companies/henogen-srl/273669c2-3349-41d3-a904-a56d90f76482

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917