FDA Inspection 1190793 — Arctic Biomaterials Oy
The FDA completed an inspection of Arctic Biomaterials Oy on Nov 17, 2022 in Tampere. 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 17, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tampere (Finland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |