ZUTAN FOODS
⚠️ Moderate Risk
FEI: 3030493386 • Nairobi • KENYA
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
ADDDRUGBIO
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2024 | 33YYY99CANDY WITHOUT CHOCOLATE N.E.C. | 3887ADDDRUGBIO | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZUTAN FOODS's FDA import refusal history?
ZUTAN FOODS (FEI: 3030493386) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2024 to 4/29/2024.
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. ZUTAN FOODS's FEI number is 3030493386.
What types of violations has ZUTAN FOODS received?
ZUTAN FOODS has been cited for 1 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 ZUTAN FOODS come from?
All FDA import refusal data for ZUTAN FOODS 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.