Radenska d.o.o.
⚠️ Moderate Risk
FEI: 3003279138 • Radenci, Radenci • SLOVENIA
FEI Number
3003279138
Location
Radenci, Radenci
Country
SLOVENIAAddress
Boraceva 37, , Radenci, Radenci, Slovenia
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
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
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).
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Atlanta District Office (ATL-DO) | |
| 10/10/2001 | 29WHT02BOTTLED SPRING OR MINERAL WATER | 482NUTRIT LBL | Detroit District Office (DET-DO) |
| 10/10/2001 | 21DHT01FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) | |
| 10/10/2001 | 21DHT01FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) | |
| 10/10/2001 | 31KHT02TEA, GREEN | Detroit District Office (DET-DO) | |
| 10/10/2001 | 31KHT02TEA, GREEN | Detroit District Office (DET-DO) | |
| 10/10/2001 | 21DHT02CITRUS, MIXED, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) | |
| 10/10/2001 | 21DHT02CITRUS, MIXED, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) | |
| 10/10/2001 | 21DHT03BERRIES, MIXED, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) | |
| 10/10/2001 | 21DHT03BERRIES, MIXED, JUICES OR CONCENTRATES | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Radenska d.o.o.'s FDA import refusal history?
Radenska d.o.o. (FEI: 3003279138) has 10 FDA import refusal record(s) in our database, spanning from 10/10/2001 to 10/3/2005.
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. Radenska d.o.o.'s FEI number is 3003279138.
What types of violations has Radenska d.o.o. received?
Radenska d.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 Radenska d.o.o. come from?
All FDA import refusal data for Radenska d.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.