MONDELEZ BRAZIL LTDA
⚠️ Moderate Risk
FEI: 3026330200 • Curitiba, Parana • BRAZIL
FEI Number
3026330200
Location
Curitiba, Parana
Country
BRAZILAddress
Avenida Juscelino Kubitschek De Oliveira, 651 S/N, , Curitiba, Parana, Brazil
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2024 | 60QBY99ANESTHETIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/21/2024 | 60QBY99ANESTHETIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/21/2024 | 60QBY99ANESTHETIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/4/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/4/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MONDELEZ BRAZIL LTDA's FDA import refusal history?
MONDELEZ BRAZIL LTDA (FEI: 3026330200) has 5 FDA import refusal record(s) in our database, spanning from 1/4/2024 to 5/21/2024.
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 BRAZIL LTDA's FEI number is 3026330200.
What types of violations has MONDELEZ BRAZIL LTDA received?
MONDELEZ BRAZIL LTDA has been cited for 3 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 BRAZIL LTDA come from?
All FDA import refusal data for MONDELEZ BRAZIL LTDA 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.