Company
United StatesMobius Imaging, LLC, Shirley, MA – FDA Inspections
Inspection records and compliance data for Mobius Imaging, LLC in Shirley, Massachusetts. 2 FDA inspections on record, 1 Form 483, last inspected April 04, 2018.
Company Profile
This profile covers Mobius Imaging, LLC based in Shirley, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 30, 2015. Last inspected April 4, 2018.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 4, 2018 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1046991 |
| June 30, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938890 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mobius Imaging, LLC
FEI Number
3010151377
Address
2 Shaker Rd Ste F100, Shirley, Massachusetts 01464, United States
Country
United States
ID: a7bc754f-4547-4c8e-bbe8-83e88528ad37