FDA Inspection 1323188 — QUANTA DIALYSIS TECHONLOGIES LIMITED
The FDA completed an inspection of QUANTA DIALYSIS TECHONLOGIES LIMITED on Jun 11, 2026 in Warwick. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warwick (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |