Company
United StatesGN Hearing Care Corporation, Shakopee, MN – FDA Inspections
Inspection records and compliance data for GN Hearing Care Corporation in Shakopee, Minnesota. 6 FDA inspections on record, 1 Form 483, last inspected January 10, 2018.
Company Profile
This profile covers GN Hearing Care Corporation based in Shakopee, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected April 22, 2009. Last inspected January 10, 2018.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1037254 |
| April 1, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 824925 |
| June 28, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 733296 |
| May 17, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 662331 |
| April 28, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 661850 |
| April 22, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 579054 |
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
GN Hearing Care Corporation
FEI Number
2182204
Address
5005 Dean Lakes Blvd, Shakopee, Minnesota 55379-2998, United States
Country
United States
ID: 0903ad7b-8e55-4b75-b741-9574a7d1824a