X-FEIYANG HK CO LIMITED-EXPORT
⚠️ Moderate Risk
FEI: 3014943625 • Hong Kong, Hong Kong • HONG KONG
FEI Number
3014943625
Location
Hong Kong, Hong Kong
Country
HONG KONGAddress
Rm D, 4/F, Century Centre, Hong Kong, Hong Kong, 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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2021 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/7/2021 | 16EYY99SHELLFISH, N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
| 6/7/2021 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/13/2021 | 73CAWGENERATOR, OXYGEN, PORTABLE | Division of Southeast Imports (DSEI) | |
| 3/30/2021 | 79FRODRESSING, WOUND, DRUG | Division of Southeast Imports (DSEI) | |
| 6/24/2019 | 73PGJOXIMETER, WELLNESS | Division of Southeast Imports (DSEI) | |
| 6/5/2019 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Northern Border Imports (DNBI) | |
| 4/9/2019 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is X-FEIYANG HK CO LIMITED-EXPORT's FDA import refusal history?
X-FEIYANG HK CO LIMITED-EXPORT (FEI: 3014943625) has 8 FDA import refusal record(s) in our database, spanning from 4/9/2019 to 6/7/2021.
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. X-FEIYANG HK CO LIMITED-EXPORT's FEI number is 3014943625.
What types of violations has X-FEIYANG HK CO LIMITED-EXPORT received?
X-FEIYANG HK CO LIMITED-EXPORT has been cited for 8 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 X-FEIYANG HK CO LIMITED-EXPORT come from?
All FDA import refusal data for X-FEIYANG HK CO LIMITED-EXPORT 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.