Go International Ltd
⚠️ Moderate Risk
FEI: 3004528781 • London • UNITED KINGDOM
FEI Number
3004528781
Location
London
Country
UNITED KINGDOMAddress
Flower Lane, Mill Hill, , London, , United Kingdom
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/9/2013 | 79OHOFIRST AID KIT WITHOUT DRUG | San Francisco District Office (SAN-DO) | |
| 7/9/2013 | 74LLKLEGGING, COMPRESSION, NON-INFLATABLE | San Francisco District Office (SAN-DO) | |
| 7/9/2013 | 74LLKLEGGING, COMPRESSION, NON-INFLATABLE | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Go International Ltd's FDA import refusal history?
Go International Ltd (FEI: 3004528781) has 4 FDA import refusal record(s) in our database, spanning from 7/9/2013 to 7/9/2013.
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. Go International Ltd's FEI number is 3004528781.
What types of violations has Go International Ltd received?
Go International Ltd 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 Go International Ltd come from?
All FDA import refusal data for Go International Ltd 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.