INDUSTRIAS LACTEAS SA

⚠️ High Risk

FEI: 3023938691 • Fraijanes, Guatemala • GUATEMALA

FEI

FEI Number

3023938691

📍

Location

Fraijanes, Guatemala

🇬🇹

Country

GUATEMALA

🏢

Address

Km 25.5 Carretera A El, , Fraijanes, Guatemala, Guatemala

High Risk

FDA Import Risk Assessment

55.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/15/2023

Latest Refusal

9/15/2023

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

31.3×30%

Recency

39.1×20%

Frequency

60.0×10%

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

Violation Summary

626×

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).

836×

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
9/15/2023	30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
9/15/2023	30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
9/15/2023	30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
9/15/2023	09CFY99MILK AND CREAM, N.E.C.	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
9/15/2023	09CFY99MILK AND CREAM, N.E.C.	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
9/15/2023	09CFY05MILK, FLAVORED (CHOCOLATE, ETC.)	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INDUSTRIAS LACTEAS SA's FDA import refusal history?

INDUSTRIAS LACTEAS SA (FEI: 3023938691) has 6 FDA import refusal record(s) in our database, spanning from 9/15/2023 to 9/15/2023.

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. INDUSTRIAS LACTEAS SA's FEI number is 3023938691.

What types of violations has INDUSTRIAS LACTEAS SA received?

INDUSTRIAS LACTEAS 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 INDUSTRIAS LACTEAS SA come from?

All FDA import refusal data for INDUSTRIAS LACTEAS 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.