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LACTEOS DE HONDURAS S.A DE CV

⚠️ High Risk

FEI: 3013779125 • Tegucigalpa, Francisco Morazan • HONDURAS

FEI

FEI Number

3013779125

📍

Location

Tegucigalpa, Francisco Morazan

🇭🇳

Country

HONDURAS
🏢

Address

21 Blvd De Octubre 21, , Tegucigalpa, Francisco Morazan, Honduras

High Risk

FDA Import Risk Assessment

52.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
4
Unique Violations
5/11/2022
Latest Refusal
4/6/2022
Earliest Refusal

Score Breakdown

Violation Severity
78.1×40%
Refusal Volume
35.3×30%
Recency
12.3×20%
Frequency
80.0×10%
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

627×

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).

837×

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.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
5/11/2022
30YFT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of Southeast Imports (DSEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/6/2022
09CGE05MILK, FLAVORED (CHOCOLATE, ETC.)
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is LACTEOS DE HONDURAS S.A DE CV's FDA import refusal history?

LACTEOS DE HONDURAS S.A DE CV (FEI: 3013779125) has 8 FDA import refusal record(s) in our database, spanning from 4/6/2022 to 5/11/2022.

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. LACTEOS DE HONDURAS S.A DE CV's FEI number is 3013779125.

What types of violations has LACTEOS DE HONDURAS S.A DE CV received?

LACTEOS DE HONDURAS S.A DE CV 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 LACTEOS DE HONDURAS S.A DE CV come from?

All FDA import refusal data for LACTEOS DE HONDURAS S.A DE CV 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.