FDA Inspection 772945 — COSMED Nordic ApS
The FDA completed an inspection of COSMED Nordic ApS on Feb 16, 2012 in Odense S. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Odense S (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |