Makaira
⚠️ Moderate Risk
FEI: 3003383783 • Guayaquil, Guayas • ECUADOR
FEI Number
3003383783
Location
Guayaquil, Guayas
Country
ECUADORAddress
Cdla Albatroz, Calle Flamingo 221, Guayaquil, Guayas, Ecuador
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
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2001 | 16AGC51MAHI MAHI | 2360HISTAMINE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Makaira's FDA import refusal history?
Makaira (FEI: 3003383783) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 10/1/2001.
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. Makaira's FEI number is 3003383783.
What types of violations has Makaira received?
Makaira 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 Makaira come from?
All FDA import refusal data for Makaira 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.