Oku-Tan International Ltd.
⚠️ Moderate Risk
FEI: 1000587346 • Lagos, Cross River State • NIGERIA
FEI Number
1000587346
Location
Lagos, Cross River State
Country
NIGERIAAddress
6 Christ Healing Church Streetketu, , Lagos, Cross River State, Nigeria
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
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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.
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.
POISON PKG
The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.
NO PERMIT
The article of milk or cream is not accompanied by a valid import milk permit, as required by the Federal Import Milk Act (21 U.S.C. 141-149).
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 |
|---|---|---|---|
| 5/8/2002 | 60LAJ99ANALGESIC, N.E.C. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 5/8/2002 | 24KEE50TOMATOES, WITH SAUCE | New Orleans District Office (NOL-DO) | |
| 5/8/2002 | 61TAR99ANTI-EMETIC/NAUSEANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 5/8/2002 | 09CMH16MILK, DRIED | New Orleans District Office (NOL-DO) | |
| 5/7/2002 | 21REE24PALM NUT (PALM FRUIT, SUGAR PALM) (SUBTROPICAL AND TROPICAL FRUIT PUREES) | New Orleans District Office (NOL-DO) | |
| 5/7/2002 | 28JYY99MIXED SPICES AND SEASONING WITH SALT, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Oku-Tan International Ltd.'s FDA import refusal history?
Oku-Tan International Ltd. (FEI: 1000587346) has 6 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 5/8/2002.
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. Oku-Tan International Ltd.'s FEI number is 1000587346.
What types of violations has Oku-Tan International Ltd. received?
Oku-Tan International Ltd. has been cited for 7 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 Oku-Tan International Ltd. come from?
All FDA import refusal data for Oku-Tan International 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.