ELIZABETH MAGALY ANIMAS CERON
⚠️ Moderate Risk
FEI: 3017221731 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3017221731
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Lirios 9, Col. Balcones De Cehuayo, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, Mexico
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(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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 4/12/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 4/12/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 10/5/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 10/5/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is ELIZABETH MAGALY ANIMAS CERON's FDA import refusal history?
ELIZABETH MAGALY ANIMAS CERON (FEI: 3017221731) has 5 FDA import refusal record(s) in our database, spanning from 10/5/2020 to 4/12/2021.
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. ELIZABETH MAGALY ANIMAS CERON's FEI number is 3017221731.
What types of violations has ELIZABETH MAGALY ANIMAS CERON received?
ELIZABETH MAGALY ANIMAS CERON has been cited for 9 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 ELIZABETH MAGALY ANIMAS CERON come from?
All FDA import refusal data for ELIZABETH MAGALY ANIMAS CERON 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.