Laboratories Vichy Div Of L'Oreal
⚠️ Moderate Risk
FEI: 3011557817 • Madrid, Madrid • SPAIN
FEI Number
3011557817
Location
Madrid, Madrid
Country
SPAINAddress
Calle Josefa Valcarcel # 48, , Madrid, Madrid, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2022 | 64XBY06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 10/2/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/2/2015 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/2/2015 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/2/2015 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/2/2015 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/2/2015 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Laboratories Vichy Div Of L'Oreal's FDA import refusal history?
Laboratories Vichy Div Of L'Oreal (FEI: 3011557817) has 12 FDA import refusal record(s) in our database, spanning from 10/2/2015 to 7/27/2022.
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. Laboratories Vichy Div Of L'Oreal's FEI number is 3011557817.
What types of violations has Laboratories Vichy Div Of L'Oreal received?
Laboratories Vichy Div Of L'Oreal has been cited for 5 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 Laboratories Vichy Div Of L'Oreal come from?
All FDA import refusal data for Laboratories Vichy Div Of L'Oreal 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.