FDA Inspection
Sensable Technologies, Inc.Sensable Technologies, Inc. – FDA Inspection, Feb 17, 2011
Record Details
This FDA Inspection record concerns Sensable Technologies, Inc., with an inspection on February 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sensable Technologies, Inc.
- Inspection Date
- February 17, 2011
- Product Type
- Devices
View Company Profile
ID · 2881ea33-0780-4873-b28f-f7aa954bc8f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Sensable Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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