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Schering Plough Farmaceutical Ltda

⚠️ High Risk

FEI: 3010969285 • Aparecida de Goiania, Goias • BRAZIL

FEI

FEI Number

3010969285

📍

Location

Aparecida de Goiania, Goias

🇧🇷

Country

BRAZIL
🏢

Address

Avenida Sebastiao Lemes Viana, DE GOIANIA, Aparecida de Goiania, Goias, Brazil

High Risk

FDA Import Risk Assessment

55.1
LowModerateHighCritical

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

Statistics

10
Total Refusals
1
Unique Violations
3/24/2016
Latest Refusal
11/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
75.1×10%
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

7510×

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
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Schering Plough Farmaceutical Ltda's FDA import refusal history?

Schering Plough Farmaceutical Ltda (FEI: 3010969285) has 10 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 3/24/2016.

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 Farmaceutical Ltda's FEI number is 3010969285.

What types of violations has Schering Plough Farmaceutical Ltda received?

Schering Plough Farmaceutical 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 Farmaceutical Ltda come from?

All FDA import refusal data for Schering Plough Farmaceutical 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.