# FDA 483 - Kamada - Production Plant - Unknown Date

Source: https://www.keypedia.com/records/483/kamada-production-plant/27b2bb22-6307-4b4d-9774-5f6a9fdb3e83

> 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: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Kamada Ltd., a drug substance and drug product manufacturer in MP Negev, Israel, revealed significant deficiencies in their manufacturing operations. Observations included inadequate process validation, failure to follow internal SOPs and use of unvalidated procedures, poor facility maintenance with power outages and water leaks, and issues with aseptic filling and product labeling. These findings indicate a lack of robust quality control and adherence to good manufacturing practices.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/kamada-production-plant/1ff2246b-c8d3-425a-a378-c919b4c3a04c)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/pete-amin/7f032e7a-1dfc-4240-ba8d-2bba5f7e5b6b)
- [Prashant Verekar](https://www.keypedia.com/people/prashant-verekar/4570576b-16c2-4334-8c46-23a10f0ddd99)
- [Olga Simakova](https://www.keypedia.com/people/olga-simakova/2ee5985e-425e-4732-8869-2be861f5d792)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4