Gutberlet Gmbh
⚠️ Moderate Risk
FEI: 3001184989 • Nuremberg, Bavaria • GERMANY
FEI Number
3001184989
Location
Nuremberg, Bavaria
Country
GERMANYAddress
Max-Brod-Str. 11, , Nuremberg, Bavaria, 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).
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 |
|---|---|---|---|
| 6/25/2018 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 12/4/2017 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/3/2015 | 53CK03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 7/17/2012 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Detroit District Office (DET-DO) |
| 7/17/2012 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Detroit District Office (DET-DO) |
| 1/20/2012 | 53CH01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 6/29/2011 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 6/29/2011 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Gutberlet Gmbh's FDA import refusal history?
Gutberlet Gmbh (FEI: 3001184989) has 19 FDA import refusal record(s) in our database, spanning from 6/29/2011 to 6/25/2018.
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. Gutberlet Gmbh's FEI number is 3001184989.
What types of violations has Gutberlet Gmbh received?
Gutberlet Gmbh has been cited for 3 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 Gutberlet Gmbh come from?
All FDA import refusal data for Gutberlet 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.