FDA Inspection 944298 — Ralco S.R.L.
The FDA completed an inspection of Ralco S.R.L. on Sep 11, 2015 in Biassono. 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
- Sep 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Biassono (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |