Hangzhou Tongyi Enterprise Co., Ltd.
⚠️ High Risk
FEI: 3038014998 • Hanzhou, Zhejiang Province • CHINA
FEI Number
3038014998
Location
Hanzhou, Zhejiang Province
Country
CHINAAddress
No. 301, Sanfeng Road, Dajiangdong Industrial Cluster, , Hanzhou, Zhejiang Province, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
UNFIT4FOOD
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/15/2026 | 31KHT20TEA, LIQUID | Division of West Coast Imports (DWCI) | |
| 7/17/2025 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | 3421MELAMINE | Division of West Coast Imports (DWCI) |
| 6/11/2025 | 29AGE70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of West Coast Imports (DWCI) | |
| 6/11/2025 | 29AGE70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hangzhou Tongyi Enterprise Co., Ltd.'s FDA import refusal history?
Hangzhou Tongyi Enterprise Co., Ltd. (FEI: 3038014998) has 4 FDA import refusal record(s) in our database, spanning from 6/11/2025 to 1/15/2026.
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. Hangzhou Tongyi Enterprise Co., Ltd.'s FEI number is 3038014998.
What types of violations has Hangzhou Tongyi Enterprise Co., Ltd. received?
Hangzhou Tongyi Enterprise 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 Hangzhou Tongyi Enterprise Co., Ltd. come from?
All FDA import refusal data for Hangzhou Tongyi Enterprise 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.