FDA Inspection 832273 — LSO Medical S.A.S
The FDA completed an inspection of LSO Medical S.A.S on May 24, 2013 in Loos. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Loos (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |