Monaco Foods, Inc.
⚠️ Moderate Risk
FEI: 2000011211 • Miami, FL • UNITED STATES
FEI Number
2000011211
Location
Miami, FL
Country
UNITED STATESAddress
1120 Nw 165th St, , Miami, FL, United States
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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2020 | 21AVE01FRUIT COCKTAIL, MIXED FRUITS | 83NO PROCESS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Monaco Foods, Inc.'s FDA import refusal history?
Monaco Foods, Inc. (FEI: 2000011211) has 1 FDA import refusal record(s) in our database, spanning from 2/5/2020 to 2/5/2020.
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. Monaco Foods, Inc.'s FEI number is 2000011211.
What types of violations has Monaco Foods, Inc. received?
Monaco Foods, Inc. 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 Monaco Foods, Inc. come from?
All FDA import refusal data for Monaco Foods, Inc. 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.