Kinbio LTDMay 26, 2022

FDA 483 - Kinbio LTD - May 26, 2022

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Record Details

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.

Company: Kinbio LTD
Inspection Date: May 26, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Lisa R. Hilliard (Consumer Safety Officer , Investigator)
Sena G. Dissmeyer

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