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Schering-Plough Compania Ltda

⚠️ Moderate Risk

FEI: 3005831960 • Santiago • CHILE

FEI

FEI Number

3005831960

📍

Location

Santiago

🇨🇱

Country

CHILE
🏢

Address

Burgos 80-Las Condes, , Santiago, , Chile

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/16/2006
Latest Refusal
10/16/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
10/16/2006
85HDTDEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Schering-Plough Compania Ltda (FEI: 3005831960) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/16/2006.

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 Compania Ltda's FEI number is 3005831960.

What types of violations has Schering-Plough Compania Ltda received?

Schering-Plough Compania 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 Compania Ltda come from?

All FDA import refusal data for Schering-Plough Compania 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.