IREX DE COSTA RICA S.A
⚠️ Moderate Risk
FEI: 3004982133 • Belen, Heredia • COSTA RICA
FEI Number
3004982133
Location
Belen, Heredia
Country
COSTA RICAAddress
200m North, Main Entrance of EPA Hardware Store, Asuncion, Belen, Heredia, Costa Rica
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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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 |
|---|---|---|---|
| 6/7/2019 | 21ICN15PRUNES (DRIED PLUMS) (PIT FRUIT PUREES) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 21ICN13PEACH (PIT FRUIT PUREES) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 21FCN01FRUIT COCKTAIL, MIXED FRUIT PUREES | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 20UCN03PEAR (CORE FRUIT PUREES) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 20UCN01APPLE (CORE FRUIT PUREES) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
| 12/18/2018 | 21ICE15PRUNES (DRIED PLUMS) (PIT FRUIT PUREES) | Division of Southeast Imports (DSEI) | |
| 12/18/2018 | 21FCE01FRUIT COCKTAIL, MIXED FRUIT PUREES | Division of Southeast Imports (DSEI) | |
| 12/18/2018 | 20UCE01APPLE (CORE FRUIT PUREES) | Division of Southeast Imports (DSEI) | |
| 12/18/2018 | 21RCI02BANANA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | Division of Southeast Imports (DSEI) | |
| 12/18/2018 | 20UCE03PEAR (CORE FRUIT PUREES) | Division of Southeast Imports (DSEI) | |
| 12/18/2018 | 20UCE01APPLE (CORE FRUIT PUREES) | Division of Southeast Imports (DSEI) | |
| 12/7/2018 | 21ICN15PRUNES (DRIED PLUMS) (PIT FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 21RCN04GUAVA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 21ICN13PEACH (PIT FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 21FCN01FRUIT COCKTAIL, MIXED FRUIT PUREES | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 20UCN01APPLE (CORE FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 21RCI02BANANA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 20UCN03PEAR (CORE FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 20UCN01APPLE (CORE FRUIT PUREES) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is IREX DE COSTA RICA S.A's FDA import refusal history?
IREX DE COSTA RICA S.A (FEI: 3004982133) has 19 FDA import refusal record(s) in our database, spanning from 12/7/2018 to 6/7/2019.
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. IREX DE COSTA RICA S.A's FEI number is 3004982133.
What types of violations has IREX DE COSTA RICA S.A received?
IREX DE COSTA RICA S.A 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 IREX DE COSTA RICA S.A come from?
All FDA import refusal data for IREX DE COSTA RICA S.A 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.