Omron Healthcare, Inc.
⚠️ Moderate Risk
FEI: 1450057 • Hoffman Estates, IL • UNITED STATES
FEI Number
1450057
Location
Hoffman Estates, IL
Country
UNITED STATESAddress
2895 Greenspoint Pkwy, , Hoffman Estates, IL, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2022 | 74DXQCUFF, BLOOD-PRESSURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/24/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/1/2003 | 74LDESTETHOSCOPE, MANUAL | Chicago District Office (CHI-DO) | |
| 5/1/2003 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) | |
| 3/31/2003 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) | |
| 3/31/2003 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) | |
| 3/31/2003 | 74LDESTETHOSCOPE, MANUAL | Chicago District Office (CHI-DO) | |
| 3/31/2003 | 74LDESTETHOSCOPE, MANUAL | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 3/19/2003 | 74LDESTETHOSCOPE, MANUAL | Chicago District Office (CHI-DO) | |
| 3/19/2003 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Omron Healthcare, Inc.'s FDA import refusal history?
Omron Healthcare, Inc. (FEI: 1450057) has 10 FDA import refusal record(s) in our database, spanning from 3/19/2003 to 8/17/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Omron Healthcare, Inc.'s FEI number is 1450057.
What types of violations has Omron Healthcare, Inc. received?
Omron Healthcare, Inc. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Omron Healthcare, Inc. come from?
All FDA import refusal data for Omron Healthcare, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.