Janssen Cosmetics GmbH
⚠️ Moderate Risk
FEI: 3004719523 • Aachen, North Rhine-Westphalia • GERMANY
FEI Number
3004719523
Location
Aachen, North Rhine-Westphalia
Country
GERMANYAddress
Pontsheide 32-36, , Aachen, North Rhine-Westphalia, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2014 | 65LAL99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/11/2014 | 65LAL99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/3/2013 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 4/3/2013 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/2/2012 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/5/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/5/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Janssen Cosmetics GmbH's FDA import refusal history?
Janssen Cosmetics GmbH (FEI: 3004719523) has 7 FDA import refusal record(s) in our database, spanning from 8/5/2010 to 9/11/2014.
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. Janssen Cosmetics GmbH's FEI number is 3004719523.
What types of violations has Janssen Cosmetics GmbH received?
Janssen Cosmetics GmbH 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 Janssen Cosmetics GmbH come from?
All FDA import refusal data for Janssen Cosmetics GmbH 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.