BCM Cosmetique SAS
⚠️ Moderate Risk
FEI: 3003412427 • Vitre, Ille Et Vilaine • FRANCE
FEI Number
3003412427
Location
Vitre, Ille Et Vilaine
Country
FRANCEAddress
Zone Industrielle La Haie Robert, 34 route des Eaux, Vitre, Ille Et Vilaine, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2025 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is BCM Cosmetique SAS's FDA import refusal history?
BCM Cosmetique SAS (FEI: 3003412427) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2025 to 8/22/2025.
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. BCM Cosmetique SAS's FEI number is 3003412427.
What types of violations has BCM Cosmetique SAS received?
BCM Cosmetique SAS has been cited for 1 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 BCM Cosmetique SAS come from?
All FDA import refusal data for BCM Cosmetique 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.