FDA Inspection 932680 — Nipro Medical Ltda
The FDA completed an inspection of Nipro Medical Ltda on May 21, 2015 in Sorocaba. 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
- May 21, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sorocaba (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |