FDA 483 - NIPRO CORP. - July 05, 2018

An FDA inspection of Nipro Corporation - Odate Factory in Odate, Japan, revealed significant deficiencies in process validation for their PATHFAST® cTnI reagent cartridge kits. The firm failed to adequately validate manufacturing processes, citing issues with single-lot validation, insufficient sample size justification, and the absence of an Operational Qualification. These findings indicate a lack of robust quality control in their medical device manufacturing.