Hugo De Amato Caracoles Sa
⚠️ Moderate Risk
FEI: 3011068081 • Medellin, Antioquia • COLOMBIA
FEI Number
3011068081
Location
Medellin, Antioquia
Country
COLOMBIAAddress
Calle 15cs 29c 23, , Medellin, Antioquia, Colombia
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.
Refusal History
Frequently Asked Questions
What is Hugo De Amato Caracoles Sa's FDA import refusal history?
Hugo De Amato Caracoles Sa (FEI: 3011068081) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2014 to 11/6/2014.
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. Hugo De Amato Caracoles Sa's FEI number is 3011068081.
What types of violations has Hugo De Amato Caracoles Sa received?
Hugo De Amato Caracoles Sa 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 Hugo De Amato Caracoles Sa come from?
All FDA import refusal data for Hugo De Amato Caracoles Sa 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.