Alpol Cosmetique
⚠️ Moderate Risk
FEI: 3006152351 • Chateau Gaillard, AIN • FRANCE
FEI Number
3006152351
Location
Chateau Gaillard, AIN
Country
FRANCEAddress
140 rue Pasteur, , Chateau Gaillard, AIN, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 5/2/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 5/2/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/2/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alpol Cosmetique's FDA import refusal history?
Alpol Cosmetique (FEI: 3006152351) has 12 FDA import refusal record(s) in our database, spanning from 5/2/2016 to 5/2/2016.
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. Alpol Cosmetique's FEI number is 3006152351.
What types of violations has Alpol Cosmetique received?
Alpol Cosmetique 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 Alpol Cosmetique come from?
All FDA import refusal data for Alpol Cosmetique 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.