Omron (Dalian) Co., Ltd. (Plant 1)
⚠️ Moderate Risk
FEI: 3001373226 • Dalian, Liaoning • CHINA
FEI Number
3001373226
Location
Dalian, Liaoning
Country
CHINAAddress
Economic, No. 3 Songjianglu; Jinzhou, Dalian, Liaoning, China
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 9/8/2015 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 9/8/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 9/8/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 9/8/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 9/8/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 9/8/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 8/26/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 3260NO ENGLISH | Florida District Office (FLA-DO) |
| 1/3/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 7/12/2011 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | 508NO 510(K) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Omron (Dalian) Co., Ltd. (Plant 1)'s FDA import refusal history?
Omron (Dalian) Co., Ltd. (Plant 1) (FEI: 3001373226) has 9 FDA import refusal record(s) in our database, spanning from 7/12/2011 to 9/8/2015.
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 (Dalian) Co., Ltd. (Plant 1)'s FEI number is 3001373226.
What types of violations has Omron (Dalian) Co., Ltd. (Plant 1) received?
Omron (Dalian) Co., Ltd. (Plant 1) 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 (Dalian) Co., Ltd. (Plant 1) come from?
All FDA import refusal data for Omron (Dalian) Co., Ltd. (Plant 1) 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.