Dongguan HengWenXin Inc.
⚠️ Moderate Risk
FEI: 3018741039 • Dongguan, Guangdong • CHINA
FEI Number
3018741039
Location
Dongguan, Guangdong
Country
CHINAAddress
172 Yong Jun Road, Da Ling Shan, Da Ling Shan Zhen, No.3 Building Room#102, Dongguan, 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
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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.
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)).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
FLAVR LBLG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2022 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 3421MELAMINE | Division of Northeast Imports (DNEI) |
| 1/25/2022 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 07AGT99BAKED SNACK FOOD, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 07AGT99BAKED SNACK FOOD, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2022 | 07JGT99GRAIN SNACKS (WHOLE, SPLIT), N.E.C., FRIED/OIL COOKED | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Dongguan HengWenXin Inc.'s FDA import refusal history?
Dongguan HengWenXin Inc. (FEI: 3018741039) has 8 FDA import refusal record(s) in our database, spanning from 1/25/2022 to 1/25/2022.
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. Dongguan HengWenXin Inc.'s FEI number is 3018741039.
What types of violations has Dongguan HengWenXin Inc. received?
Dongguan HengWenXin Inc. 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 Dongguan HengWenXin Inc. come from?
All FDA import refusal data for Dongguan HengWenXin Inc. 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.