Huini Beauty Co
⚠️ Moderate Risk
FEI: 3007308033 • Guangzhou, Guangdong • CHINA
FEI Number
3007308033
Location
Guangzhou, Guangdong
Country
CHINAAddress
2 Nankeng Dong, , Guangzhou, Guangdong, 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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
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 |
|---|---|---|---|
| 10/9/2013 | 80MDZCLEANERS, MEDICAL DEVICES | San Francisco District Office (SAN-DO) | |
| 10/9/2013 | 80MDZCLEANERS, MEDICAL DEVICES | San Francisco District Office (SAN-DO) | |
| 5/14/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 5/14/2013 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/14/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Huini Beauty Co's FDA import refusal history?
Huini Beauty Co (FEI: 3007308033) has 5 FDA import refusal record(s) in our database, spanning from 5/14/2013 to 10/9/2013.
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. Huini Beauty Co's FEI number is 3007308033.
What types of violations has Huini Beauty Co received?
Huini Beauty Co 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 Huini Beauty Co come from?
All FDA import refusal data for Huini Beauty Co 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.