Company
United StatesEdlen Imaging, LLC, Scottsdale, AZ – FDA Inspections
Inspection records and compliance data for Edlen Imaging, LLC in Scottsdale, Arizona. 1 FDA inspection on record, 1 Form 483, last inspected October 12, 2017.
Company Profile
This profile covers Edlen Imaging, LLC based in Scottsdale, Arizona, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected October 12, 2017.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Complaints1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028486 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Edlen Imaging, LLC
FEI Number
3009596768
Address
16441 N 91st St Ste 102, Scottsdale, Arizona 85260, United States
Country
United States
ID: e4226cd3-4747-4a47-8c68-076ae1ef65a6