FDA Inspection 631790 — Varian Medical Systems, Inc.
The FDA completed an inspection of Varian Medical Systems, Inc. on November 18, 2009 in Austin, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |