FDA Inspection 663960 — Amo Groningen BV
The FDA completed an inspection of Amo Groningen BV on April 22, 2010 in Groningen. 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
- April 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Groningen (Netherlands)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |