Company
United StatesDMG America LLC dba Goldsmith & Revere, Inc., Englewood, NJ – FDA Inspections
Inspection records and compliance data for DMG America LLC dba Goldsmith & Revere, Inc. in Englewood, New Jersey. 5 FDA inspections on record, last inspected November 12, 2015.
Company Profile
This profile covers DMG America LLC dba Goldsmith & Revere, Inc. based in Englewood, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected July 7, 2010. Last inspected November 12, 2015.
Most cited issue areas
- Investigation of device failures2 inspections
- Documentation of validated process performance1 inspection
- Lack of or inadequate organizational structure1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 12, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 951941 |
| November 13, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 854944 |
| January 29, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 816472 |
| March 20, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 770501 |
| July 7, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 670226 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
DMG America LLC dba Goldsmith & Revere, Inc.
FEI Number
2244812
Address
242 S Dean St, Englewood, New Jersey 07631, United States
Country
United States
ID: bc61e3c5-b5ee-4820-b2d5-c23655a2572c