Gmc International Ltd
⚠️ Moderate Risk
FEI: 3006013583 • Kowloon • HONG KONG
FEI Number
3006013583
Location
Kowloon
Country
HONG KONGAddress
3 Salisbury Road, , Kowloon, , Hong Kong
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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/27/2007 | 76EFWTOOTHBRUSH, MANUAL | Seattle District Office (SEA-DO) | |
| 4/27/2007 | 61HBL99ANTI-BACTERIAL, N.E.C. | Seattle District Office (SEA-DO) | |
| 4/27/2007 | 61HBL99ANTI-BACTERIAL, N.E.C. | Seattle District Office (SEA-DO) | |
| 4/27/2007 | 62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Seattle District Office (SEA-DO) | |
| 4/27/2007 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Gmc International Ltd's FDA import refusal history?
Gmc International Ltd (FEI: 3006013583) has 5 FDA import refusal record(s) in our database, spanning from 4/27/2007 to 4/27/2007.
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. Gmc International Ltd's FEI number is 3006013583.
What types of violations has Gmc International Ltd received?
Gmc 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 Gmc International Ltd come from?
All FDA import refusal data for Gmc 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.