HORTEX SP.Z.O.O
⚠️ Moderate Risk
FEI: 3013361661 • Warsaw, Mazowieckie • POLAND
FEI Number
3013361661
Location
Warsaw, Mazowieckie
Country
POLANDAddress
Ul. Mszczonowska 2, , Warsaw, Mazowieckie, Poland
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
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).
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.
CYCLAMATE
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2013 | 20DFT05CURRANTS, BLACK, JUICE OR CONCENTRATES | New York District Office (NYK-DO) | |
| 5/27/2011 | 29AFT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED | 2640CYCLAMATE | New York District Office (NYK-DO) |
| 5/27/2011 | 29AFT02SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED | New York District Office (NYK-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT01CARROT, JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT01CARROT, JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/26/2008 | 25MHT01CARROT, JUICE OR DRINK | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is HORTEX SP.Z.O.O's FDA import refusal history?
HORTEX SP.Z.O.O (FEI: 3013361661) has 18 FDA import refusal record(s) in our database, spanning from 3/26/2008 to 7/18/2013.
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. HORTEX SP.Z.O.O's FEI number is 3013361661.
What types of violations has HORTEX SP.Z.O.O received?
HORTEX SP.Z.O.O has been cited for 4 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 HORTEX SP.Z.O.O come from?
All FDA import refusal data for HORTEX 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.