Company
United StatesGeneral Devices Llc, Ridgefield, NJ – FDA Inspections
Inspection records and compliance data for General Devices Llc in Ridgefield, New Jersey. 4 FDA inspections on record (1 OAI), last inspected March 30, 2017.
Company Profile
This profile covers General Devices Llc based in Ridgefield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 29, 2010. Last inspected March 30, 2017.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Investigation of device failures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1018328 |
| June 11, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 931039 |
| December 14, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 812713 |
| July 29, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678182 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
General Devices Llc
FEI Number
2244646
Address
1000 River St, Ridgefield, New Jersey 07657, United States
Country
United States
ID: 2ab2cc56-b870-4fc9-9a3f-f8bd76bc5cea