Company
United StatesElmed Incorporated, Glendale Heights, IL – FDA Inspections
Inspection records and compliance data for Elmed Incorporated in Glendale Heights, Illinois. 6 FDA inspections on record, 1 Form 483, last inspected July 17, 2023.
Company Profile
This profile covers Elmed Incorporated based in Glendale Heights, Illinois, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected June 17, 2009. Last inspected July 17, 2023.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1210243 |
| April 12, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1088027 |
| September 21, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 986692 |
| August 12, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 891957 |
| March 7, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 712807 |
| June 17, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 590843 |
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
Elmed Incorporated
FEI Number
1412854
Address
35 N Brandon Dr, Glendale Heights, Illinois 60139, United States
Country
United States
ID: f3366bb2-c0d3-421e-b5e8-745604783131