FDA Inspection 1314916 — Medify Air LLC
The FDA completed an inspection of Medify Air LLC on Apr 23, 2026 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |