Infasa
⚠️ High Risk
FEI: 3007180545 • Mixco, Guatemala • GUATEMALA
FEI Number
3007180545
Location
Mixco, Guatemala
Country
GUATEMALAAddress
15.5 Roosevelt St, , Mixco, Guatemala, Guatemala
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 66MBA99TRANQUILIZER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2025 | 65RBL99REPLENISHER N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/23/2025 | 62UDL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 61GDY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2021 | 62LDY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2017 | 64LCK19DEXAMETHASONE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Infasa's FDA import refusal history?
Infasa (FEI: 3007180545) has 8 FDA import refusal record(s) in our database, spanning from 10/31/2017 to 12/9/2025.
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. Infasa's FEI number is 3007180545.
What types of violations has Infasa received?
Infasa has been cited for 2 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 Infasa come from?
All FDA import refusal data for Infasa 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.