FDA Inspection 1303546 — EUSA Global, LLC
The FDA completed an inspection of EUSA Global, LLC on February 6, 2026 in Medley, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23033 | ISO 13485:2016 Clause 4.2.1 | QMS documentation does not include required documents |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |