# FDA 483 - Henogen SRL - November 22, 2024

Source: https://www.keypedia.com/records/483/henogen-srl/2b8c2510-c4d6-4ff8-995d-f8e56407bf37

> 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: Office of Inspections and Investigations
- Summary: An FDA inspection of Henogen SRL, a viral vector manufacturer in Seneffe, Belgium, revealed a significant deficiency in control data related to the manufacturing of viral vectors. Specifically, the firm's batch records lacked adequate reconciliation of production yield and criteria for investigating excessively high or low yields. This indicates a potential lack of robust process control for critical manufacturing steps.

## Related Documents

- [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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8