FDA Inspection
DMG America LLC dba Goldsmith & Revere, Inc.DMG America LLC dba Goldsmith & Revere, Inc. – FDA Inspection, Jan 29, 2013
Record Details
This FDA Inspection record concerns DMG America LLC dba Goldsmith & Revere, Inc., with an inspection on January 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 29, 2013
- Product Type
- Devices
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ID · f4469103-e68d-470d-8a38-8379fa0768fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816472
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DMG America LLC dba Goldsmith & Revere, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: 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 951941 - 2015-11-12
- FDA Inspection 854944 - 2013-11-13
- FDA Inspection 770501 - 2012-03-20
- FDA Inspection 670226 - 2010-07-07
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