Dr Med Christine Schrammek Kosmetik
⚠️ Moderate Risk
FEI: 3002585052 • Essen, North Rhine-Westphalia • GERMANY
FEI Number
3002585052
Location
Essen, North Rhine-Westphalia
Country
GERMANYAddress
Kibbelstr. 6, , Essen, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Atlanta District Office (ATL-DO) |
| 8/24/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/24/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dr Med Christine Schrammek Kosmetik's FDA import refusal history?
Dr Med Christine Schrammek Kosmetik (FEI: 3002585052) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2010 to 5/23/2014.
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. Dr Med Christine Schrammek Kosmetik's FEI number is 3002585052.
What types of violations has Dr Med Christine Schrammek Kosmetik received?
Dr Med Christine Schrammek Kosmetik 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 Dr Med Christine Schrammek Kosmetik come from?
All FDA import refusal data for Dr Med Christine Schrammek Kosmetik 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.