FDA Inspection 1062329 — Vygon GmbH & Co. KG
The FDA completed an inspection of Vygon GmbH & Co. KG on Aug 16, 2018 in Aachen. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Aachen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |