FDA 483 - Actegy Health Inc. - May 07, 2026

An FDA inspection of Actegy Health Inc., an initial importer in Rosemont, IL, revealed significant deficiencies in its quality management system. The firm failed to document essential procedures and records for its QMS processes, including documentation requirements, management responsibility, and product realization. Additionally, the company lacked written procedures for assessing and reporting adverse events as medical device reports (MDRs).