Company
United StatesMeridian Medical Systems LLC, Aurora, OH – FDA Inspections
Inspection records and compliance data for Meridian Medical Systems LLC in Aurora, Ohio. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected February 24, 2017.
Company Profile
This profile covers Meridian Medical Systems LLC based in Aurora, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 31, 2013. Last inspected February 24, 2017.
Most cited issue areas
- Design history file1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DHR content1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1002415 |
| May 15, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 878130 |
| May 31, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 832897 |
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
Meridian Medical Systems LLC
FEI Number
3008492862
Address
325 Harris Dr, Aurora, Ohio 44202, United States
Country
United States
ID: d0e598f3-8e83-49b0-b743-8b0cceffcfa9