Chantelet S.A Laboratorios Cosmeticos
⚠️ Moderate Risk
FEI: 3005384763 • Madrid, Madrid • SPAIN
FEI Number
3005384763
Location
Madrid, Madrid
Country
SPAINAddress
Calle Del Corral De Cantos, , Madrid, Madrid, Spain
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 6/29/2006 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Chantelet S.A Laboratorios Cosmeticos's FDA import refusal history?
Chantelet S.A Laboratorios Cosmeticos (FEI: 3005384763) has 9 FDA import refusal record(s) in our database, spanning from 6/29/2006 to 6/29/2006.
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. Chantelet S.A Laboratorios Cosmeticos's FEI number is 3005384763.
What types of violations has Chantelet S.A Laboratorios Cosmeticos received?
Chantelet S.A Laboratorios Cosmeticos 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 Chantelet S.A Laboratorios Cosmeticos come from?
All FDA import refusal data for Chantelet S.A Laboratorios Cosmeticos 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.