Jean D'Arcel Cosmetique
⚠️ Moderate Risk
FEI: 3002512998 • Kehl, Baden-Wurttemberg • GERMANY
FEI Number
3002512998
Location
Kehl, Baden-Wurttemberg
Country
GERMANYAddress
Postfach 1526, , Kehl, Baden-Wurttemberg, Germany
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).
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 |
|---|---|---|---|
| 11/23/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/23/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/23/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/16/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 2/16/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Jean D'Arcel Cosmetique's FDA import refusal history?
Jean D'Arcel Cosmetique (FEI: 3002512998) has 18 FDA import refusal record(s) in our database, spanning from 2/16/2007 to 11/23/2009.
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. Jean D'Arcel Cosmetique's FEI number is 3002512998.
What types of violations has Jean D'Arcel Cosmetique received?
Jean D'Arcel Cosmetique 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 Jean D'Arcel Cosmetique come from?
All FDA import refusal data for Jean D'Arcel 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.