FDA Inspection
VogueStrapVogueStrap – FDA Inspection, Mar 16, 2018
Record Details
This FDA Inspection record concerns VogueStrap, with an inspection on March 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5ffae8dc-f4f2-423d-bce7-f9af986c78d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044757
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(b)Incoming acceptance records, documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VogueStrap
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for VogueStrap
- FDA Inspection 887478 - 2014-07-16
- FDA Inspection 752537 - 2011-11-04
- FDA Inspection 639981 - 2010-01-21
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