Cosmeticos Elicina LTDA.
⚠️ High Risk
FEI: 3004474609 • Santiago • CHILE
FEI Number
3004474609
Location
Santiago
Country
CHILEAddress
Padre Orellana 1319, , Santiago, , Chile
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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(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.
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 |
|---|---|---|---|
| 9/30/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 9/3/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/3/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/3/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/24/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/24/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/24/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/2/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/8/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/17/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Cosmeticos Elicina LTDA.'s FDA import refusal history?
Cosmeticos Elicina LTDA. (FEI: 3004474609) has 12 FDA import refusal record(s) in our database, spanning from 11/17/2004 to 9/30/2024.
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. Cosmeticos Elicina LTDA.'s FEI number is 3004474609.
What types of violations has Cosmeticos Elicina LTDA. received?
Cosmeticos Elicina LTDA. 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 Cosmeticos Elicina LTDA. come from?
All FDA import refusal data for Cosmeticos Elicina LTDA. 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.