FDA Inspection 1035361 — Laboratoires Urgo
The FDA completed an inspection of Laboratoires Urgo on Dec 14, 2017 in Chevigny St Sauveur. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 14, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chevigny St Sauveur (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |