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Schering Plough Industria Farmaceutica Ltda.

⚠️ Moderate Risk

FEI: 3008613462 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3008613462

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Joao Alfredo 353, , Sao Paulo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/16/2014
Latest Refusal
4/16/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
4/16/2014
64GDA29LEVONORGESTREL (ESTROGEN)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Schering Plough Industria Farmaceutica Ltda.'s FDA import refusal history?

Schering Plough Industria Farmaceutica Ltda. (FEI: 3008613462) has 1 FDA import refusal record(s) in our database, spanning from 4/16/2014 to 4/16/2014.

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. Schering Plough Industria Farmaceutica Ltda.'s FEI number is 3008613462.

What types of violations has Schering Plough Industria Farmaceutica Ltda. received?

Schering Plough Industria Farmaceutica Ltda. has been cited for 1 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 Schering Plough Industria Farmaceutica Ltda. come from?

All FDA import refusal data for Schering Plough Industria Farmaceutica Ltda. 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.