Mlle Kebe Fanta
⚠️ Moderate Risk
FEI: 3004716478 • Conakry • GUINEA
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2004 | 16AGN99FISH, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 12/8/2004 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 12/8/2004 | 56BCE07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mlle Kebe Fanta's FDA import refusal history?
Mlle Kebe Fanta (FEI: 3004716478) has 3 FDA import refusal record(s) in our database, spanning from 12/8/2004 to 12/8/2004.
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. Mlle Kebe Fanta's FEI number is 3004716478.
What types of violations has Mlle Kebe Fanta received?
Mlle Kebe Fanta 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 Mlle Kebe Fanta come from?
All FDA import refusal data for Mlle Kebe Fanta 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.