Labothene
⚠️ Moderate Risk
FEI: 3003511804 • Pforzheim, Baden-Wurttemberg • GERMANY
FEI Number
3003511804
Location
Pforzheim, Baden-Wurttemberg
Country
GERMANYAddress
Gulichstr. 5, ALLEMAGNE, Pforzheim, Baden-Wurttemberg, 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
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.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2008 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 1/9/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 1/9/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 1/9/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 53MC02INDOOR TANNING PREPARATIONS (SUNTAN PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | New Orleans District Office (NOL-DO) | |
| 5/15/2007 | 61SAL99ANTI-ECZEMATIC N.E.C. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 5/15/2007 | 61SAL99ANTI-ECZEMATIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/1/2006 | 65LBJ99PROTECTANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/22/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Labothene's FDA import refusal history?
Labothene (FEI: 3003511804) has 20 FDA import refusal record(s) in our database, spanning from 7/22/2003 to 1/9/2008.
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. Labothene's FEI number is 3003511804.
What types of violations has Labothene received?
Labothene has been cited for 8 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 Labothene come from?
All FDA import refusal data for Labothene 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.