Lancome
⚠️ Moderate Risk
FEI: 3005975048 • Caudry • FRANCE
FEI Number
3005975048
Location
Caudry
Country
FRANCEAddress
Soe314- Sicos Et Cie, Ave Henri, , Caudry, , France
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2016 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/27/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2015 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/19/2014 | 66VD99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2014 | 66VD99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/28/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/28/2014 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/23/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/1/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 5/13/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3741FRNMFGREG | Division of Southeast Imports (DSEI) |
| 4/16/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/13/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/13/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/13/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/13/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/22/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/1/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 5/17/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/17/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/17/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/17/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/17/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lancome's FDA import refusal history?
Lancome (FEI: 3005975048) has 30 FDA import refusal record(s) in our database, spanning from 5/17/2012 to 8/15/2016.
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. Lancome's FEI number is 3005975048.
What types of violations has Lancome received?
Lancome 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 Lancome come from?
All FDA import refusal data for Lancome 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.