GOPAK LTD
⚠️ High Risk
FEI: 3008905876 • Magilev Dnestrovsk, Vinnytska Oblast • UKRAINE
FEI Number
3008905876
Location
Magilev Dnestrovsk, Vinnytska Oblast
Country
UKRAINEAddress
Dnestrovskaya Street 60, , Magilev Dnestrovsk, Vinnytska Oblast, Ukraine
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/29/2014 | 24FCE01EGG PLANT (FRUIT USED AS VEGETABLE) | Division of Northeast Imports (DNEI) | |
| 1/29/2014 | 24FCE01EGG PLANT (FRUIT USED AS VEGETABLE) | Division of Northeast Imports (DNEI) | |
| 8/22/2011 | 27YCE06PEPPER SAUCE (HOT, MILD, ETC.) | New York District Office (NYK-DO) | |
| 6/10/2011 | 25ECE99MIXED VEGETABLES, N.E.C. | New York District Office (NYK-DO) | |
| 6/10/2011 | 25MCE01CARROT, JUICE OR DRINK | New York District Office (NYK-DO) | |
| 6/10/2011 | 25ECE99MIXED VEGETABLES, N.E.C. | New York District Office (NYK-DO) | |
| 6/10/2011 | 25ECE99MIXED VEGETABLES, N.E.C. | New York District Office (NYK-DO) | |
| 6/10/2011 | 24FCP20CUCUMBERS (FRUIT USED AS VEGETABLE) | New York District Office (NYK-DO) | |
| 6/10/2011 | 24FCP07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | New York District Office (NYK-DO) | |
| 6/10/2011 | 24KCE01EGG PLANT, WITH SAUCE | New York District Office (NYK-DO) | |
| 6/10/2011 | 24KCE06SQUASH, SUMMER, WITH SAUCE | New York District Office (NYK-DO) | |
| 6/10/2011 | 24HCE01EGG PLANT, DRIED OR PASTE | New York District Office (NYK-DO) | |
| 6/10/2011 | 24FCP07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | New York District Office (NYK-DO) | |
| 6/10/2011 | 24FCP20CUCUMBERS (FRUIT USED AS VEGETABLE) | New York District Office (NYK-DO) | |
| 6/10/2011 | 25ECP99MIXED VEGETABLES, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is GOPAK LTD's FDA import refusal history?
GOPAK LTD (FEI: 3008905876) has 15 FDA import refusal record(s) in our database, spanning from 6/10/2011 to 1/29/2014.
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. GOPAK LTD's FEI number is 3008905876.
What types of violations has GOPAK LTD received?
GOPAK LTD has been cited for 2 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 GOPAK LTD come from?
All FDA import refusal data for GOPAK LTD 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.