FORTUNA Sp. z o.o.
⚠️ High Risk
FEI: 3009929902 • Zdunska Wola, Lodzkie • POLAND
FEI Number
3009929902
Location
Zdunska Wola, Lodzkie
Country
POLANDAddress
Ul. Tymienicka 88, , Zdunska Wola, Lodzkie, Poland
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 30BEB06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 83NO PROCESS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FORTUNA Sp. z o.o.'s FDA import refusal history?
FORTUNA Sp. z o.o. (FEI: 3009929902) has 7 FDA import refusal record(s) in our database, spanning from 7/11/2025 to 7/11/2025.
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. FORTUNA Sp. z o.o.'s FEI number is 3009929902.
What types of violations has FORTUNA Sp. z o.o. received?
FORTUNA Sp. z o.o. 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 FORTUNA Sp. z o.o. come from?
All FDA import refusal data for FORTUNA Sp. z o.o. 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.