Shenzhen Xin Yongtong Im&Ex Co Ltd
⚠️ Moderate Risk
FEI: 3009588663 • Shenzhen • CHINA
FEI Number
3009588663
Location
Shenzhen
Country
CHINAAddress
Room No D2202 Jihao Buildingeast Of The, , Shenzhen, , 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
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)).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2013 | 21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | 249FILTHY | Southwest Import District Office (SWI-DO) |
| 12/14/2012 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 12/14/2012 | 25LGT99ROOT & TUBER VEGETABLE, DRIED OR PASTE, N.E.C. | Chicago District Office (CHI-DO) | |
| 12/14/2012 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 12/14/2012 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 12/14/2012 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Shenzhen Xin Yongtong Im&Ex Co Ltd's FDA import refusal history?
Shenzhen Xin Yongtong Im&Ex Co Ltd (FEI: 3009588663) has 6 FDA import refusal record(s) in our database, spanning from 12/14/2012 to 2/6/2013.
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. Shenzhen Xin Yongtong Im&Ex Co Ltd's FEI number is 3009588663.
What types of violations has Shenzhen Xin Yongtong Im&Ex Co Ltd received?
Shenzhen Xin Yongtong Im&Ex Co Ltd has been cited for 9 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 Shenzhen Xin Yongtong Im&Ex Co Ltd come from?
All FDA import refusal data for Shenzhen Xin Yongtong Im&Ex Co 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.