Inner Mongolia Yili Industrial Group Co., Ltd.
⚠️ High Risk
FEI: 3016525063 • Hohhot, CN-15 • CHINA
FEI Number
3016525063
Location
Hohhot, CN-15
Country
CHINAAddress
No. 1, Jinshan Street, Jinshan Development Zone, , Hohhot, CN-15, 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:
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
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.
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.
INCONSPICU
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(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 |
|---|---|---|---|
| 1/30/2025 | 29AGT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of Northeast Imports (DNEI) | |
| 1/30/2025 | 29AGT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of Northeast Imports (DNEI) | |
| 1/30/2025 | 29AGT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of Northeast Imports (DNEI) | |
| 1/13/2025 | 29AGT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of Northeast Imports (DNEI) | |
| 1/13/2025 | 29AGT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | Division of Northeast Imports (DNEI) | |
| 12/10/2024 | 29AGT03SOFT DRINK, CORE FRUIT FLAVORED, NONCARBONATED | 3421MELAMINE | Division of Northeast Imports (DNEI) |
| 12/10/2024 | 29AGT03SOFT DRINK, CORE FRUIT FLAVORED, NONCARBONATED | 3421MELAMINE | Division of Northeast Imports (DNEI) |
| 12/10/2024 | 29AGT03SOFT DRINK, CORE FRUIT FLAVORED, NONCARBONATED | 3421MELAMINE | Division of Northeast Imports (DNEI) |
| 10/27/2020 | 30JGT04BEVERAGE BASE, IMITATION MIXED FRUIT | 3421MELAMINE | Division of Northeast Imports (DNEI) |
| 9/28/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 9/28/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 9/28/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 5/1/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 5/1/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 5/1/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) | |
| 5/1/2020 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Inner Mongolia Yili Industrial Group Co., Ltd.'s FDA import refusal history?
Inner Mongolia Yili Industrial Group Co., Ltd. (FEI: 3016525063) has 16 FDA import refusal record(s) in our database, spanning from 5/1/2020 to 1/30/2025.
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. Inner Mongolia Yili Industrial Group Co., Ltd.'s FEI number is 3016525063.
What types of violations has Inner Mongolia Yili Industrial Group Co., Ltd. received?
Inner Mongolia Yili Industrial Group Co., Ltd. has been cited for 13 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 Inner Mongolia Yili Industrial Group Co., Ltd. come from?
All FDA import refusal data for Inner Mongolia Yili Industrial Group 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.