# FDA 483 - Kamada - Production Plant - Unknown Date

Source: https://www.keypedia.com/records/483/kamada-production-plant/1ff2246b-c8d3-425a-a378-c919b4c3a04c

> FDA 483 for Kamada - Production Plant on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kamada - Production Plant
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Kamada Ltd., a drug substance and product manufacturer in MP Negev, Israel, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process validation and use of unvalidated procedures for Cytogam manufacturing, facilities not in a state of good repair with recurring power outages and water leaks, and issues during aseptic filling setup. Additionally, the firm lacked adequate written procedures for drug substance labeling.

## Related Officers

- [Olga Simakova](https://www.keypedia.com/people/olga-simakova/2ee5985e-425e-4732-8869-2be861f5d792)
- [Pete Ambe](https://www.keypedia.com/people/pete-ambe/574c12d7-ff4c-4e3d-89b7-fac7f1c5a960)
- [Prashant Vankayala](https://www.keypedia.com/people/prashant-vankayala/ef9c9342-a9b6-4c3b-9c0f-a693dcef5d30)

Company: https://www.keypedia.com/companies/kamada-production-plant/d3a7a962-b08c-4278-8951-5cad5bcfed41

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd