Umgroup Limited
⚠️ Moderate Risk
FEI: 3009023220 • Tangshan • CHINA
FEI Number
3009023220
Location
Tangshan
Country
CHINAAddress
328 Teachers College, , Tangshan, , 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2012 | 76KLCCHAIR WITH UNIT | New York District Office (NYK-DO) | |
| 9/22/2011 | 76ELCSCALER, ULTRASONIC | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76ELCSCALER, ULTRASONIC | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EKYHANDPIECE, WATER-POWERED | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EHBCOLLIMATOR, X-RAY | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EHBCOLLIMATOR, X-RAY | Southwest Import District Office (SWI-DO) | |
| 9/22/2011 | 76EIAUNIT, OPERATIVE DENTAL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Umgroup Limited's FDA import refusal history?
Umgroup Limited (FEI: 3009023220) has 9 FDA import refusal record(s) in our database, spanning from 9/22/2011 to 8/14/2012.
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. Umgroup Limited's FEI number is 3009023220.
What types of violations has Umgroup Limited received?
Umgroup Limited has been cited for 5 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 Umgroup Limited come from?
All FDA import refusal data for Umgroup Limited 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.