FDA Inspection
VirtexVirtex – FDA Inspection, Mar 26, 2013
Record Details
This FDA Inspection record concerns Virtex, with an inspection on March 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Virtex
- Inspection Date
- March 26, 2013
- Product Type
- Devices
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ID · edfa3fd4-dfde-4375-a318-ead8b3342836
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823538
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Virtex
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Virtex
- FDA Inspection 1214397 - 2023-08-02
- FDA Inspection 1025962 - 2017-09-21
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