# FDA 483 - Kinbio LTD - May 26, 2022

Source: https://www.keypedia.com/records/483/kinbio-ltd/cc50fab1-897c-4c3f-9a11-6e1dbecfeec5

> FDA 483 for Kinbio LTD on May 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kinbio LTD
- Inspection Date: 2022-05-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: KinBio Ltd. in Rehovot, Israel, an active pharmaceutical ingredient manufacturer, received two observations during an FDA inspection. The firm was cited for unclear written procedures regarding production and process controls, including validation and cleaning. Additionally, the inspection revealed a failure to thoroughly review unexplained discrepancies, indicating significant concerns with their quality systems.

## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.keypedia.com/companies/kinbio-ltd/47ec32e7-45dd-43d9-a5b1-fb614012a5ed

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1