Company
United StatesOmron Healthcare, Inc., Hoffman Estates, IL – FDA Inspections
Inspection records and compliance data for Omron Healthcare, Inc. in Hoffman Estates, Illinois. 2 FDA inspections on record, last inspected March 22, 2012.
Company Profile
This profile covers Omron Healthcare, Inc. based in Hoffman Estates, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 13, 2011. Last inspected March 22, 2012.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Evaluation, timeliness, identification1 inspection
- Investigation of device failures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 772787 |
| May 13, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 731708 |
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
Omron Healthcare, Inc.
FEI Number
1450057
Address
2895 Greenspoint Pkwy, Hoffman Estates, Illinois 60169, United States
Country
United States
ID: c110d68e-b6b6-4f81-a962-0fff593b0af2