Lendan Cosmetica Tecnica
⚠️ Moderate Risk
FEI: 1000461486 • Sant Boi de Llobregat, Barcelona • SPAIN
FEI Number
1000461486
Location
Sant Boi de Llobregat, Barcelona
Country
SPAINAddress
Carretera de Santa Creu de Calafell 97, , Sant Boi de Llobregat, Barcelona, Spain
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
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).
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2011 | 53LH08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 62GBY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 62MAJ01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/15/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/15/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/23/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 9/23/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 2/20/2007 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/20/2007 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/20/2007 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Southeast Imports (DSEI) | |
| 1/30/2004 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/8/2003 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/8/2003 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/8/2003 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/8/2003 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/16/2002 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 12/16/2002 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/16/2002 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/15/2002 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lendan Cosmetica Tecnica's FDA import refusal history?
Lendan Cosmetica Tecnica (FEI: 1000461486) has 49 FDA import refusal record(s) in our database, spanning from 11/15/2002 to 2/23/2011.
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. Lendan Cosmetica Tecnica's FEI number is 1000461486.
What types of violations has Lendan Cosmetica Tecnica received?
Lendan Cosmetica Tecnica has been cited for 4 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 Lendan Cosmetica Tecnica come from?
All FDA import refusal data for Lendan Cosmetica Tecnica 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.