Linea Nivnice A.S.
⚠️ Moderate Risk
FEI: 3009652496 • Nivnice, Brno-mesto • CZECH REPUBLIC
FEI Number
3009652496
Location
Nivnice, Brno-mesto
Country
CZECH REPUBLICAddress
U Dvora 190, , Nivnice, Brno-mesto, Czech Republic
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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 |
|---|---|---|---|
| 5/15/2013 | 20SFT01APPLE, CORE FRUIT JUICES OR CONCENTRATES | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 5/29/2012 | 20SCE99CORE FRUIT JUICES OR CONCENTRATES, N.E.C. | New York District Office (NYK-DO) | |
| 10/23/2006 | 21VFE05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 10/23/2006 | 40ECE05SUBTROPICAL AND TROPICAL FRUIT, JUICE AND DRINK (BABY) | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 10/23/2006 | 40DCE99VEGETABLES, N.E.C. (BABY) | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 10/23/2006 | 40KCE03BANANA PUDDING AND CUSTARD (BABY) | 62NEEDS FCE | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Linea Nivnice A.S.'s FDA import refusal history?
Linea Nivnice A.S. (FEI: 3009652496) has 6 FDA import refusal record(s) in our database, spanning from 10/23/2006 to 5/15/2013.
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. Linea Nivnice A.S.'s FEI number is 3009652496.
What types of violations has Linea Nivnice A.S. received?
Linea Nivnice A.S. 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 Linea Nivnice A.S. come from?
All FDA import refusal data for Linea Nivnice A.S. 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.