FDA 483 - Home Health US, Incorporated - November 20, 2023

An FDA inspection of Home Health US, Incorporated, an initial importer/distributor in Myakka City, FL, revealed significant deficiencies in its quality system. The firm failed to establish written procedures for critical processes including complaint handling, Medical Device Reporting, and corrective and preventive actions. These findings indicate a lack of fundamental controls necessary to ensure product quality and regulatory compliance.