ONETIK
⚠️ High Risk
FEI: 3004265685 • Macaye, Pyrenees Atlantiques • FRANCE
FEI Number
3004265685
Location
Macaye, Pyrenees Atlantiques
Country
FRANCEAddress
252 route Departementale 119, , Macaye, Pyrenees Atlantiques, France
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
LISTERIA
The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
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).
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
LACKS FIRM
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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2024 | 12CGP12SOFT RIPENED CHEESE MADE FROM GOAT'S MILK (E.G., CHEVRE, FETA, GOAT) | 295LISTERIA | Division of West Coast Imports (DWCI) |
| 6/17/2013 | 12CGP16CHEESE, SHEEP, N.E.C. | 295LISTERIA | San Francisco District Office (SAN-DO) |
| 5/8/2013 | 12AWP52CHEESE, SEMISOFT | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 12/21/2010 | 12CGP99CHEESE PRODUCTS, NON-STANDARDIZED, N.E.C. | 295LISTERIA | Florida District Office (FLA-DO) |
| 3/27/2009 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 295LISTERIA | Florida District Office (FLA-DO) |
| 2/19/2009 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 295LISTERIA | Division of Southeast Imports (DSEI) |
| 12/31/2008 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 295LISTERIA | Florida District Office (FLA-DO) |
| 8/11/2008 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 295LISTERIA | Florida District Office (FLA-DO) |
| 7/31/2008 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 295LISTERIA | Florida District Office (FLA-DO) |
| 7/25/2007 | 12AGP99CHEESE (STANDARDIZED),N.E.C. | 308MFR INSAN | Division of Southeast Imports (DSEI) |
| 11/6/2006 | 12CGP16CHEESE, SHEEP, N.E.C. | 295LISTERIA | Los Angeles District Office (LOS-DO) |
| 10/17/2006 | 12CGP16CHEESE, SHEEP, N.E.C. | 295LISTERIA | New York District Office (NYK-DO) |
| 10/26/2005 | 12CGP12SOFT RIPENED CHEESE MADE FROM GOAT'S MILK (E.G., CHEVRE, FETA, GOAT) | 295LISTERIA | New York District Office (NYK-DO) |
| 7/13/2005 | 12CGP12SOFT RIPENED CHEESE MADE FROM GOAT'S MILK (E.G., CHEVRE, FETA, GOAT) | 295LISTERIA | New York District Office (NYK-DO) |
| 4/26/2005 | 12AGP52CHEESE, SEMISOFT | New England District Office (NWE-DO) | |
| 10/26/2004 | 12AGP56SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT) | 295LISTERIA | New York District Office (NYK-DO) |
| 1/24/2002 | 12CGP15CHEESE, GOAT, N.E.C. | 295LISTERIA | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ONETIK's FDA import refusal history?
ONETIK (FEI: 3004265685) has 17 FDA import refusal record(s) in our database, spanning from 1/24/2002 to 10/4/2024.
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. ONETIK's FEI number is 3004265685.
What types of violations has ONETIK received?
ONETIK has been cited for 6 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 ONETIK come from?
All FDA import refusal data for ONETIK 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.