Company
United StatesWR Medical Electronics Company, Maplewood, MN – FDA Inspections
Inspection records and compliance data for WR Medical Electronics Company in Maplewood, Minnesota. 4 FDA inspections on record, last inspected June 22, 2017.
Company Profile
This profile covers WR Medical Electronics Company based in Maplewood, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected April 17, 2009. Last inspected June 22, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 22, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1019808 |
| April 29, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 876738 |
| January 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 768896 |
| April 17, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 579002 |
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
WR Medical Electronics Company
FEI Number
2118418
Address
1700 Gervais Ave, Maplewood, Minnesota 55109, United States
Country
United States
ID: c2df6ee6-965e-43e4-8b2d-d4a6c22cb70d