FDA Inspection 1070529 — R82 A/S
The FDA completed an inspection of R82 A/S on Nov 1, 2018 in Gedved. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: 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. |