Eureka Cosmetica, S.A. de C.V.
⚠️ High Risk
FEI: 3015143794 • Zapopan, Jalisco • MEXICO
FEI Number
3015143794
Location
Zapopan, Jalisco
Country
MEXICOAddress
Calle Villa Juarez Calle Francisco Sarabia 53, Otro Francisco Sarabia, Zapopan, Zapopan, Jalisco, Mexico
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/2/2021 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/26/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/16/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 2/18/2020 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Eureka Cosmetica, S.A. de C.V.'s FDA import refusal history?
Eureka Cosmetica, S.A. de C.V. (FEI: 3015143794) has 16 FDA import refusal record(s) in our database, spanning from 2/18/2020 to 6/2/2021.
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. Eureka Cosmetica, S.A. de C.V.'s FEI number is 3015143794.
What types of violations has Eureka Cosmetica, S.A. de C.V. received?
Eureka Cosmetica, S.A. de C.V. 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 Eureka Cosmetica, S.A. de C.V. come from?
All FDA import refusal data for Eureka Cosmetica, S.A. de C.V. 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.