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Okenke Limitedimport-Export

⚠️ Moderate Risk

FEI: 3005959724 • Lagos, Cross River State • NIGERIA

FEI

FEI Number

3005959724

📍

Location

Lagos, Cross River State

🇳🇬

Country

NIGERIA
🏢

Address

512 Road, A Close, Block 3,Flat 1festac, , Lagos, Cross River State, Nigeria

Moderate Risk

FDA Import Risk Assessment

34.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
4
Unique Violations
11/30/2011
Latest Refusal
11/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
56.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
39.9×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2181×

LIST INGRE

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 it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

621×

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).

831×

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

DateProductViolationsDivision
11/30/2011
29BGT60SODA WATER, CARBONATED
473LABELING
New York District Office (NYK-DO)
11/30/2011
29BGT60SODA WATER, CARBONATED
473LABELING
New York District Office (NYK-DO)
11/30/2011
29BGT60SODA WATER, CARBONATED
218LIST INGRE
New York District Office (NYK-DO)
11/29/2010
21VCP24PALM NUT (PALM FRUIT, SUGAR PALM), JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Okenke Limitedimport-Export's FDA import refusal history?

Okenke Limitedimport-Export (FEI: 3005959724) has 4 FDA import refusal record(s) in our database, spanning from 11/29/2010 to 11/30/2011.

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. Okenke Limitedimport-Export's FEI number is 3005959724.

What types of violations has Okenke Limitedimport-Export received?

Okenke Limitedimport-Export 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 Okenke Limitedimport-Export come from?

All FDA import refusal data for Okenke Limitedimport-Export 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.