Orgev Laboratoires
⚠️ Moderate Risk
FEI: 3004534998 • Rambouillet, Yvelines • FRANCE
FEI Number
3004534998
Location
Rambouillet, Yvelines
Country
FRANCEAddress
19 Rue Du Debuche, , Rambouillet, Yvelines, France
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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2007 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/3/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 9/13/2005 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/27/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Orgev Laboratoires's FDA import refusal history?
Orgev Laboratoires (FEI: 3004534998) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2004 to 11/7/2007.
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. Orgev Laboratoires's FEI number is 3004534998.
What types of violations has Orgev Laboratoires received?
Orgev Laboratoires 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 Orgev Laboratoires come from?
All FDA import refusal data for Orgev Laboratoires 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.