PRODUCTOS FARMAC UTICOS
⚠️ High Risk
FEI: 3013550854 • M Xico • MEXICO
FEI Number
3013550854
Location
M Xico
Country
MEXICOAddress
Lago Tanga Ica N M. 18, , M Xico, , 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
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 |
|---|---|---|---|
| 10/14/2025 | 62GRY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 62VDE13RIMANTADINE HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 61FCY43KITASAMYCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PRODUCTOS FARMAC UTICOS's FDA import refusal history?
PRODUCTOS FARMAC UTICOS (FEI: 3013550854) has 5 FDA import refusal record(s) in our database, spanning from 10/12/2017 to 10/14/2025.
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. PRODUCTOS FARMAC UTICOS's FEI number is 3013550854.
What types of violations has PRODUCTOS FARMAC UTICOS received?
PRODUCTOS FARMAC UTICOS 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 PRODUCTOS FARMAC UTICOS come from?
All FDA import refusal data for PRODUCTOS FARMAC UTICOS 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.