MONDELEZ INTERNATIONAL
⚠️ High Risk
FEI: 3014565362 • East Hanovereast Hanover, NJ • UNITED STATES
FEI Number
3014565362
Location
East Hanovereast Hanover, NJ
Country
UNITED STATESAddress
100 Deporest Ave, , East Hanovereast Hanover, NJ, United States
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
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.
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).
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.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
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 |
|---|---|---|---|
| 1/14/2026 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Northern Border Imports (DNBI) | |
| 1/14/2026 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Northern Border Imports (DNBI) | |
| 11/3/2023 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 11/3/2023 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 11/3/2023 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 11/3/2023 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MONDELEZ INTERNATIONAL's FDA import refusal history?
MONDELEZ INTERNATIONAL (FEI: 3014565362) has 6 FDA import refusal record(s) in our database, spanning from 11/3/2023 to 1/14/2026.
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. MONDELEZ INTERNATIONAL's FEI number is 3014565362.
What types of violations has MONDELEZ INTERNATIONAL received?
MONDELEZ INTERNATIONAL has been cited for 7 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 MONDELEZ INTERNATIONAL come from?
All FDA import refusal data for MONDELEZ INTERNATIONAL 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.