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Dfass Uruguay

⚠️ Moderate Risk

FEI: 3009690236 • Montevideo • URUGUAY

FEI

FEI Number

3009690236

📍

Location

Montevideo

🇺🇾

Country

URUGUAY
🏢

Address

Carrasco Airport, , Montevideo, , Uruguay

Moderate Risk

FDA Import Risk Assessment

31.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/7/2012
Latest Refusal
11/7/2012
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

2313×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
11/7/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
Division of Northeast Imports (DNEI)
11/7/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
Division of Northeast Imports (DNEI)
11/7/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Dfass Uruguay's FDA import refusal history?

Dfass Uruguay (FEI: 3009690236) has 3 FDA import refusal record(s) in our database, spanning from 11/7/2012 to 11/7/2012.

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. Dfass Uruguay's FEI number is 3009690236.

What types of violations has Dfass Uruguay received?

Dfass Uruguay 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 Dfass Uruguay come from?

All FDA import refusal data for Dfass Uruguay 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.