Green World Group
⚠️ Moderate Risk
FEI: 3008386795 • Tianjin • CHINA
FEI Number
3008386795
Location
Tianjin
Country
CHINAAddress
No 123 West 11th Rd, , Tianjin, , 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2013 | 85HHDPAD, MENSTRUAL, UNSCENTED | Detroit District Office (DET-DO) | |
| 4/29/2013 | 85HHDPAD, MENSTRUAL, UNSCENTED | Detroit District Office (DET-DO) | |
| 4/29/2013 | 85HHDPAD, MENSTRUAL, UNSCENTED | Detroit District Office (DET-DO) | |
| 4/29/2013 | 85HHDPAD, MENSTRUAL, UNSCENTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Green World Group's FDA import refusal history?
Green World Group (FEI: 3008386795) has 4 FDA import refusal record(s) in our database, spanning from 4/29/2013 to 4/29/2013.
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. Green World Group's FEI number is 3008386795.
What types of violations has Green World Group received?
Green World Group has been cited for 4 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 Green World Group come from?
All FDA import refusal data for Green World Group 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.