FDA Inspection 1092676 — Lune Group Oy Ltd.
The FDA completed an inspection of Lune Group Oy Ltd. on June 5, 2019 in Juupajoki. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Juupajoki (Finland)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |