FDA Inspection 1021427 — VARIAN MEDICAL SYSTEMS HAAN GMBH
The FDA completed an inspection of VARIAN MEDICAL SYSTEMS HAAN GMBH on July 20, 2017 in Haan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Haan (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |