FDA 483 - Continuity Health Solutions, LLC

An FDA inspection of Continuity Health Solutions, LLC in Dallas, TX, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately investigate device complaints, establish proper procedures for evaluating complaints for Medical Device Reporting (MDR) reportability, and create an FDA Electronic Submissions Gateway (ESG) account for electronic MDRs. Additionally, their Class II Ally™ Software System was found to be non-compliant with Unique Device Identification (UDI) requirements.