FDA Inspection
Sensable Technologies, Inc.Sensable Technologies, Inc. – FDA Inspection, Mar 23, 2012
Record Details
This FDA Inspection record concerns Sensable Technologies, Inc., with an inspection on March 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sensable Technologies, Inc.
- Inspection Date
- March 23, 2012
- Product Type
- Devices
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ID · 1c519179-af8e-47b8-bda1-6f286ba11e6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773999
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Sensable Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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