FDA Inspection 802355 — ALN S.A.R.L.
The FDA completed an inspection of ALN S.A.R.L. on September 13, 2012 in Bormes-Les-Mimosas. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bormes-Les-Mimosas (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3159 | 21 CFR 820.184 | DHR content |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |