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Jordan Sweden Medical And Sterilization

⚠️ Moderate Risk

FEI: 3007512484 • Naur • JORDAN

FEI

FEI Number

3007512484

📍

Location

Naur

🇯🇴

Country

JORDAN
🏢

Address

Naur, , Naur, , Jordan

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/26/2009
Latest Refusal
5/26/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
5/26/2009
62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/26/2009
62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Jordan Sweden Medical And Sterilization's FDA import refusal history?

Jordan Sweden Medical And Sterilization (FEI: 3007512484) has 2 FDA import refusal record(s) in our database, spanning from 5/26/2009 to 5/26/2009.

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. Jordan Sweden Medical And Sterilization's FEI number is 3007512484.

What types of violations has Jordan Sweden Medical And Sterilization received?

Jordan Sweden Medical And Sterilization 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 Jordan Sweden Medical And Sterilization come from?

All FDA import refusal data for Jordan Sweden Medical And Sterilization 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.