Company
United StatesArobella Medical, LLC, Minnetonka, MN – FDA Inspections
Inspection records and compliance data for Arobella Medical, LLC in Minnetonka, Minnesota. 6 FDA inspections on record, last inspected May 24, 2016.
Company Profile
This profile covers Arobella Medical, LLC based in Minnetonka, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected June 3, 2009. Last inspected May 24, 2016.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 988502 |
| October 30, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 806110 |
| September 13, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 799193 |
| June 25, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 788325 |
| February 10, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 767959 |
| June 3, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 588209 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Arobella Medical, LLC
FEI Number
3007225330
Address
111 Cheshire Ln Ste 700, Minnetonka, Minnesota 55305, United States
Country
United States
ID: ca6b07dd-c522-4619-841a-fe8664a638fd