FDA Inspection
Medify Air LLCMedify Air LLC – FDA Inspection, Apr 23, 2026
Record Details
This FDA Inspection record concerns Medify Air LLC, with an inspection on April 23, 2026, issued by the Center for Devices and Radiological Health.
- Company
- Medify Air LLC
- Inspection Date
- April 23, 2026
View Company Profile
ID · e0ae1f51-497c-4e52-af8e-c4b3204c1722
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1314916
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- 21 CFR 803Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.