ImportRefusal LogoImportRefusal

Los Nietitos Sa

⚠️ Moderate Risk

FEI: 3003135651 • Montevideo • URUGUAY

FEI

FEI Number

3003135651

📍

Location

Montevideo

🇺🇾

Country

URUGUAY
🏢

Address

20 De Enero 3618/22, , Montevideo, , Uruguay

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
1/15/2003
Latest Refusal
1/15/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

622×

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).

832×

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

DateProductViolationsDivision
1/15/2003
24HHT06SQUASH, SUMMER, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
1/15/2003
25LHT12SWEET POTATO, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Los Nietitos Sa's FDA import refusal history?

Los Nietitos Sa (FEI: 3003135651) has 2 FDA import refusal record(s) in our database, spanning from 1/15/2003 to 1/15/2003.

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. Los Nietitos Sa's FEI number is 3003135651.

What types of violations has Los Nietitos Sa received?

Los Nietitos 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 Los Nietitos Sa come from?

All FDA import refusal data for Los Nietitos 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.