FDA 483 - National Biological Corp - March 13, 2020

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.