An FDA warning letter highlights deficiencies in a medical device company’s CAPA quality data analysis procedures, emphasizing the critical need for robust, statistically justified trending
A major medical device company faced a recidivist FDA warning letter due to repeated quality system issues and engaged QualityHub for comprehensive audits and remediation
A global cardiovascular health company facing severe FDA compliance issues, including a corporate warning letter and multiple recalls, partnered with QualityHub to address urgent regulatory
A global cardiovascular health leader faced a corporate FDA warning letter due to multiple recalls and quality failures, prompting a comprehensive, multi-year remediation effort led