Company
United StatesARB Medical, LLC, Minnetonka, MN – FDA Inspections
Inspection records and compliance data for ARB Medical, LLC in Minnetonka, Minnesota. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected July 26, 2016.
Company Profile
This profile covers ARB Medical, LLC based in Minnetonka, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected June 15, 2011. Last inspected July 26, 2016.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 980012 |
| August 11, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 938871 |
| June 15, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 735896 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ARB Medical, LLC
FEI Number
3005770977
Address
111 Cheshire Ln Ste 700, Minnetonka, Minnesota 55305, United States
Country
United States
ID: b5f819dd-0f85-4834-8045-8d44f6440bc2