Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh
⚠️ Moderate Risk
FEI: 3000243267 • Salzhemmendorf • GERMANY
FEI Number
3000243267
Location
Salzhemmendorf
Country
GERMANYAddress
Unknown Street, , Salzhemmendorf, , 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
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2012 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/15/2012 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 10/21/2010 | 66VAO99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 8/23/2010 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 8/23/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 8/23/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 8/23/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 8/23/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 7/16/2010 | 53GK06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/16/2010 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh's FDA import refusal history?
Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh (FEI: 3000243267) has 53 FDA import refusal record(s) in our database, spanning from 7/16/2010 to 8/27/2012.
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. Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh's FEI number is 3000243267.
What types of violations has Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh received?
Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh has been cited for 6 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 Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh come from?
All FDA import refusal data for Logona Naturkosmetik Und Heilmittel Hans Hansel 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.