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

Source: https://www.keypedia.com/records/483/home-health-us-incorporated/258eb09f-88d7-48e0-abd0-4bbf968ec91c

> FDA 483 for Home Health US, Incorporated on November 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Home Health US, Incorporated
- Inspection Date: 2023-11-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/home-health-us-incorporated/919848ee-dda6-46f0-8c16-050eeeb52a72

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6