Klapp Cosmetics Gmbh
⚠️ Moderate Risk
FEI: 3003386988 • Hessisch Lichtenau, Hesse • GERMANY
FEI Number
3003386988
Location
Hessisch Lichtenau, Hesse
Country
GERMANYAddress
Hanroder Str. 24, , Hessisch Lichtenau, Hesse, 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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 5/16/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 5/16/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 5/16/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 3/9/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 330UNSAFE COL | New York District Office (NYK-DO) |
| 3/9/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 3/9/2011 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 3/9/2011 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 3/9/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/9/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/1/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 7/1/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/1/2008 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/1/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/1/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/1/2008 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Klapp Cosmetics Gmbh's FDA import refusal history?
Klapp Cosmetics Gmbh (FEI: 3003386988) has 16 FDA import refusal record(s) in our database, spanning from 7/1/2008 to 5/16/2011.
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. Klapp Cosmetics Gmbh's FEI number is 3003386988.
What types of violations has Klapp Cosmetics Gmbh received?
Klapp Cosmetics Gmbh 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 Klapp Cosmetics Gmbh come from?
All FDA import refusal data for Klapp Cosmetics 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.