483
National Biological CorpFDA 483 - National Biological Corp - March 13, 2020
Record Details
An FDA inspection of National Biological Corp in Beachwood, OH, a medical device manufacturer, identified five significant quality system deficiencies. The firm lacked adequate procedures for in-process product acceptance, process parameter monitoring, risk analysis, supplier management, and design change controls. These findings indicate a systemic failure to establish and adhere to robust quality processes, potentially impacting product quality and safety.
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ID · 7e195170-89aa-41fe-9aa6-903e34acc746