# Medify Air LLC – FDA 483, Apr 23, 2026

Source: https://www.keypedia.com/records/483/medify-air-llc/1dfb73f5-26fe-4189-b711-76e7f9665248

> FDA 483 for Medify Air LLC on April 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medify Air LLC
- Inspection Date: 2026-04-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Medify Air LLC in Boca Raton, FL, a specification developer of medical devices, was cited with four observations during an FDA inspection. The firm failed to document its quality management system, establish and maintain medical device files and design and development files for its air cleaners, and develop written procedures for medical device reporting (MDRs). These findings indicate significant deficiencies in the firm's quality system and regulatory compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/medify-air-llc/24227d6e-a0a4-4712-9b95-acfb2e4bef49

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