FDA Inspection 594594 — Polyganics Holding BV
The FDA completed an inspection of Polyganics Holding BV on June 18, 2009 in Groningen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Groningen (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |