Winback Sas
⚠️ Moderate Risk
FEI: 3011355541 • Villeneuve Loubet, Alpes Maritimes • FRANCE
FEI Number
3011355541
Location
Villeneuve Loubet, Alpes Maritimes
Country
FRANCEAddress
885 avenue Docteur Julien Lefebvre, , Villeneuve Loubet, Alpes Maritimes, 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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2016 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
| 6/13/2016 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
| 6/13/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Winback Sas's FDA import refusal history?
Winback Sas (FEI: 3011355541) has 3 FDA import refusal record(s) in our database, spanning from 6/13/2016 to 6/13/2016.
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. Winback Sas's FEI number is 3011355541.
What types of violations has Winback Sas received?
Winback Sas 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 Winback Sas come from?
All FDA import refusal data for Winback Sas 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.