FDA Inspection
Varian Medical Systems, Inc.Varian Medical Systems, Inc. – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns Varian Medical Systems, Inc., with an inspection on November 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Varian Medical Systems, Inc.
- Inspection Date
- November 18, 2009
- Product Type
- Devices
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ID · c05442b7-7921-46fb-805e-8782c08ee2ac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 631790
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Varian Medical Systems, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Varian Medical Systems, Inc.
- FDA Inspection 928587 - 2015-05-20
- FDA Inspection 752321 - 2011-10-19
- FDA Inspection 567174 - 2009-02-10
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