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

Source: https://www.keypedia.com/records/483/actegy-health-inc/640d2030-ea77-4e6f-ae34-cc542caf50e1

> FDA 483 for Actegy Health Inc. on May 07, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actegy Health Inc.
- Inspection Date: 2026-05-07
- Product Type: device
- Office Name: FDA District Office — Maitland, Florida
- Summary: 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).

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/actegy-health-inc/bd464eb2-9a7a-43c2-9c66-33014214d086

Office: https://www.keypedia.com/offices/fda-district-office-maitland-florida/21c74b3e-3f27-47f7-b852-842877c60a3a