FDA Inspection
Spentech, Inc.Spentech, Inc. – FDA Inspection, Feb 4, 2015
Record Details
This FDA Inspection record concerns Spentech, Inc., with an inspection on February 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spentech, Inc.
- Inspection Date
- February 4, 2015
- Product Type
- Devices
View Company Profile
ID · b4a8ef94-3b40-40b4-8a64-bfd4693388ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912557
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, 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 |
| March 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: 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 821840 - 2013-03-19
- FDA Inspection 735761 - 2011-07-21
- FDA Inspection 608313 - 2009-08-26
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