# FDA 483 - Kamada, Ltd. - February 03, 2010

Source: https://www.keypedia.com/records/483/kamada-ltd/ecfd3473-4dd1-4176-9cfc-b5e7a0d02ba3

> FDA 483 for Kamada, Ltd. on February 03, 2010. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kamada, Ltd.
- Inspection Date: 2010-02-03
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA Pre-License Inspection of Kamada, Ltd. in Negev, Israel, for their Alpha-1-Proteinase Inhibitor product, identified 13 significant observations. The findings highlight critical deficiencies in aseptic processing, sterilization validation, environmental monitoring, and quality control documentation. These issues indicate a need for improved controls to ensure product sterility and overall quality.

## Related Officers

- [J. David Dohm](https://www.keypedia.com/people/j-david-dohm/1c00f91c-6532-408c-8c15-62af4583bb37)
- [investigator](https://www.keypedia.com/people/ewa-marszal/99a58182-3534-4af8-a64d-e463b2f60226)

Company: https://www.keypedia.com/companies/kamada-ltd/df8beb53-fd42-4e3b-b0d7-578e6235014e

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4