Canal Export, SRL
⚠️ Moderate Risk
FEI: 3010131795 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3010131795
Location
Santo Domingo De Guzman, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Calle Proyecto, , Santo Domingo De Guzman, Distrito Nacional, Dominican Republic
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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2018 | 21WCE39CASHEW FRUIT, SUBTROPICAL AND TROPICAL FRUIT, TOPPINGS OR SYRUPS | Division of Northeast Imports (DNEI) | |
| 3/16/2018 | 21WCE06PAPAYA (PAPAW), TOPPING OR SYRUP | Division of Northeast Imports (DNEI) | |
| 10/21/2002 | 60SBR99ANTACID, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Canal Export, SRL's FDA import refusal history?
Canal Export, SRL (FEI: 3010131795) has 3 FDA import refusal record(s) in our database, spanning from 10/21/2002 to 3/16/2018.
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. Canal Export, SRL's FEI number is 3010131795.
What types of violations has Canal Export, SRL received?
Canal Export, SRL has been cited for 4 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 Canal Export, SRL come from?
All FDA import refusal data for Canal Export, SRL 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.