Emifarma, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3005884141 • Mexico • MEXICO
FEI Number
3005884141
Location
Mexico
Country
MEXICOAddress
Alolfo Lopez Mateos No. 5, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2020 | 63HDY25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Emifarma, S.A. De C.V.'s FDA import refusal history?
Emifarma, S.A. De C.V. (FEI: 3005884141) has 1 FDA import refusal record(s) in our database, spanning from 5/29/2020 to 5/29/2020.
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. Emifarma, S.A. De C.V.'s FEI number is 3005884141.
What types of violations has Emifarma, S.A. De C.V. received?
Emifarma, S.A. De C.V. has been cited for 1 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 Emifarma, S.A. De C.V. come from?
All FDA import refusal data for Emifarma, 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.