FDA Inspection 1182049 — COSMED Nordic ApS
The FDA completed an inspection of COSMED Nordic ApS on October 26, 2022 in Odense S. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 26, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Odense S (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |