M.E.G. Gottlieb Diaderma-Haus
⚠️ Moderate Risk
FEI: 3005179253 • Heidebrg • GERMANY
FEI Number
3005179253
Location
Heidebrg
Country
GERMANYAddress
Am Taubenfeld 25, , Heidebrg, , 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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 |
|---|---|---|---|
| 4/29/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 8/4/2011 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/19/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 4/19/2007 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 4/19/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 4/19/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 4/19/2007 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is M.E.G. Gottlieb Diaderma-Haus's FDA import refusal history?
M.E.G. Gottlieb Diaderma-Haus (FEI: 3005179253) has 7 FDA import refusal record(s) in our database, spanning from 4/19/2007 to 4/29/2015.
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. M.E.G. Gottlieb Diaderma-Haus's FEI number is 3005179253.
What types of violations has M.E.G. Gottlieb Diaderma-Haus received?
M.E.G. Gottlieb Diaderma-Haus 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 M.E.G. Gottlieb Diaderma-Haus come from?
All FDA import refusal data for M.E.G. Gottlieb Diaderma-Haus 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.