FDA Inspection 1070529 — R82 A/S
The FDA completed an inspection of R82 A/S on November 1, 2018 in Gedved. 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
- November 1, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gedved (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3409 | 21 CFR 820.200(d) | Service reports |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |