FDA Inspection
TENSproducts, LLCTENSproducts, LLC – FDA Inspection, Oct 31, 2011
Record Details
This FDA Inspection record concerns TENSproducts, LLC, with an inspection on October 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TENSproducts, LLC
- Inspection Date
- October 31, 2011
- Product Type
- Devices
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ID · 9afc3d97-772d-4c73-90a9-cb54366712df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752304
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Showing 10 of 12 citations.
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Other FDA inspections of TENSproducts, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 1, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for TENSproducts, LLC
- FDA Inspection 1073144 - 2018-11-06
- FDA Inspection 909806 - 2014-10-01
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