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Stragen Chemical

⚠️ Moderate Risk

FEI: 3003738048 • Geneva, Geneva • SWITZERLAND

FEI

FEI Number

3003738048

📍

Location

Geneva, Geneva

🇨🇭
🏢

Address

rue Hugo- de-Senger 3, , Geneva, Geneva, Switzerland

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/26/2010
Latest Refusal
12/19/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.5×10%
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

753×

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
7/26/2010
61LCA99ANTI-COAGULANT, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/3/2009
65LCA99PROTECTANT N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/19/2007
54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Stragen Chemical's FDA import refusal history?

Stragen Chemical (FEI: 3003738048) has 3 FDA import refusal record(s) in our database, spanning from 12/19/2007 to 7/26/2010.

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. Stragen Chemical's FEI number is 3003738048.

What types of violations has Stragen Chemical received?

Stragen Chemical 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 Stragen Chemical come from?

All FDA import refusal data for Stragen Chemical 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.