FDA Inspection 592357 — Interacoustics A/S
The FDA completed an inspection of Interacoustics A/S on June 26, 2009 in Middelfart. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Middelfart (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |