FDA Inspection
Spentech, Inc.Spentech, Inc. – FDA Inspection, Mar 19, 2013
Record Details
This FDA Inspection record concerns Spentech, Inc., with an inspection on March 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spentech, Inc.
- Inspection Date
- March 19, 2013
- Product Type
- Devices
View Company Profile
ID · 6082bf67-9d59-4a82-94a1-4091b508a8b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821840
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spentech, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 4, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spentech, Inc.
- FDA Inspection 1020883 - 2017-07-27
- FDA Inspection 912557 - 2015-02-04
- FDA Inspection 735761 - 2011-07-21
- FDA Inspection 608313 - 2009-08-26
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