FDA Inspection
Futrex Tech, Inc.Futrex Tech, Inc. – FDA Inspection, Jan 23, 2009
Record Details
This FDA Inspection record concerns Futrex Tech, Inc., with an inspection on January 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Futrex Tech, Inc.
- Inspection Date
- January 23, 2009
- Product Type
- Devices
View Company Profile
ID · 489a93e8-2230-4643-9895-f81f71c2cb17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 559035
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(g)(1)Activity documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Futrex Tech, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Futrex Tech, Inc.
- FDA Inspection 975765 - 2016-06-21
- FDA Inspection 836440 - 2013-06-17
- FDA Inspection 804015 - 2012-11-05
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