Qingdao Huafan International Trading
⚠️ Moderate Risk
FEI: 3009043622 • Qingdao, Shandong • CHINA
FEI Number
3009043622
Location
Qingdao, Shandong
Country
CHINAAddress
63 Haierlu, Laoshan, Qingdao, Shandong, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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 |
|---|---|---|---|
| 8/21/2013 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 2/28/2013 | 54YCA06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 2120UNSFDIETSP | Division of Northeast Imports (DNEI) |
| 12/15/2011 | 66VDZ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Qingdao Huafan International Trading's FDA import refusal history?
Qingdao Huafan International Trading (FEI: 3009043622) has 3 FDA import refusal record(s) in our database, spanning from 12/15/2011 to 8/21/2013.
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. Qingdao Huafan International Trading's FEI number is 3009043622.
What types of violations has Qingdao Huafan International Trading received?
Qingdao Huafan International Trading 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 Qingdao Huafan International Trading come from?
All FDA import refusal data for Qingdao Huafan International Trading 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.