Abaxis Inc – FDA 483, Aug 8, 2008

Abaxis, Inc., a medical device manufacturer in Union City, CA, was cited for significant deficiencies across its quality system. The inspection revealed failures in controlling non-conforming products, establishing and implementing complaint handling and corrective/preventive action procedures, and adhering to medical device reporting requirements. These issues indicate a systemic lack of adherence to quality system regulations, potentially impacting product quality and patient safety.