FDA Inspection
DMG America LLC dba Goldsmith & Revere, Inc.DMG America LLC dba Goldsmith & Revere, Inc. – FDA Inspection, Nov 12, 2015
Record Details
This FDA Inspection record concerns DMG America LLC dba Goldsmith & Revere, Inc., with an inspection on November 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2015
- Product Type
- Devices
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ID · c3521fbf-d778-49dd-9f41-d5e3c2f269a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951941
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of DMG America LLC dba Goldsmith & Revere, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 7, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DMG America LLC dba Goldsmith & Revere, Inc.
- FDA Inspection 854944 - 2013-11-13
- FDA Inspection 816472 - 2013-01-29
- FDA Inspection 770501 - 2012-03-20
- FDA Inspection 670226 - 2010-07-07
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