Lancaster Group Duty Free Gmbh
⚠️ Moderate Risk
FEI: 3002299714 • Rheninstrasse Mainz • GERMANY
FEI Number
3002299714
Location
Rheninstrasse Mainz
Country
GERMANYAddress
Fort Malakoff Park 3rd Floor, , Rheninstrasse Mainz, , 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 |
|---|---|---|---|
| 6/5/2006 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/5/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/5/2006 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/5/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/2/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/25/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/2/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/6/2006 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/10/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/10/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/6/2005 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/6/2005 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/4/2005 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/5/2004 | 65LBJ99PROTECTANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/17/2004 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lancaster Group Duty Free Gmbh's FDA import refusal history?
Lancaster Group Duty Free Gmbh (FEI: 3002299714) has 16 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 6/5/2006.
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. Lancaster Group Duty Free Gmbh's FEI number is 3002299714.
What types of violations has Lancaster Group Duty Free Gmbh received?
Lancaster Group Duty Free Gmbh 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 Lancaster Group Duty Free Gmbh come from?
All FDA import refusal data for Lancaster Group Duty Free 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.