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Schering Pharmaceuticals

⚠️ Moderate Risk

FEI: 3003319432 • Dorval, QC • CANADA

FEI

FEI Number

3003319432

📍

Location

Dorval, QC

🇨🇦

Country

CANADA
🏢

Address

2110 Trans Canada Hwy, , Dorval, QC, Canada

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
9/12/2007
Latest Refusal
9/12/2007
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
9/12/2007
65JCA31PROGESTERONE (PROGESTIN)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Schering Pharmaceuticals's FDA import refusal history?

Schering Pharmaceuticals (FEI: 3003319432) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2007 to 9/12/2007.

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 Pharmaceuticals's FEI number is 3003319432.

What types of violations has Schering Pharmaceuticals received?

Schering Pharmaceuticals 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 Pharmaceuticals come from?

All FDA import refusal data for Schering Pharmaceuticals 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.