FDA Inspection 848044 — Medicrea International
The FDA completed an inspection of Medicrea International on Jun 19, 2013 in Rillieux-la-pape. 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
- Jun 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rillieux-la-pape (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 4430 | 21 CFR 803.18(d)(1) | Distributor responsibilities for complaint records |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |