FDA Inspection 849997 — Medart A /S
The FDA completed an inspection of Medart A /S on Sep 13, 2013 in Hvidovre. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Hvidovre (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |