Schwan Cosmetics Cr S R.O.
⚠️ High Risk
FEI: 3005539702 • Domoradice, Jihocesky • CZECH REPUBLIC
FEI Number
3005539702
Location
Domoradice, Jihocesky
Country
CZECH REPUBLICAddress
Prumyslova 176, , Domoradice, Jihocesky, Czech Republic
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2022 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/19/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Northeast Imports (DNEI) |
| 11/13/2015 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Cincinnati District Office (CIN-DO) |
| 9/28/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 9/21/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 8/24/2015 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 8/26/2009 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/26/2009 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Schwan Cosmetics Cr S R.O.'s FDA import refusal history?
Schwan Cosmetics Cr S R.O. (FEI: 3005539702) has 28 FDA import refusal record(s) in our database, spanning from 8/26/2009 to 3/10/2022.
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. Schwan Cosmetics Cr S R.O.'s FEI number is 3005539702.
What types of violations has Schwan Cosmetics Cr S R.O. received?
Schwan Cosmetics Cr S R.O. has been cited for 5 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 Schwan Cosmetics Cr S R.O. come from?
All FDA import refusal data for Schwan Cosmetics Cr S R.O. 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.