FDA Inspection 600305 — LDR Medical
The FDA completed an inspection of LDR Medical on Jul 9, 2009 in Sainte-Savine Aube. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sainte-Savine Aube (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3330 | 21 CFR 820.181(d) | DMR packaging and labeling specifications |