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Sonia De Fatima Pereira Dias

⚠️ Moderate Risk

FEI: 3005254081 • Ipatinga, Minas Gerais • BRAZIL

FEI

FEI Number

3005254081

📍

Location

Ipatinga, Minas Gerais

🇧🇷

Country

BRAZIL
🏢

Address

Rua Leonardo Motta 202, , Ipatinga, Minas Gerais, Brazil

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/27/2005
Latest Refusal
9/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/27/2005
66FAF99SUPPRESSANT N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sonia De Fatima Pereira Dias's FDA import refusal history?

Sonia De Fatima Pereira Dias (FEI: 3005254081) has 1 FDA import refusal record(s) in our database, spanning from 9/27/2005 to 9/27/2005.

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. Sonia De Fatima Pereira Dias's FEI number is 3005254081.

What types of violations has Sonia De Fatima Pereira Dias received?

Sonia De Fatima Pereira Dias 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 Sonia De Fatima Pereira Dias come from?

All FDA import refusal data for Sonia De Fatima Pereira Dias 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.