FDA Inspection 737692 — Cablon Medical B.V.
The FDA completed an inspection of Cablon Medical B.V. on July 21, 2011 in Leusden. 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
- July 21, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leusden (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |