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Swedish Orphan Biovitrum International AB

⚠️ Moderate Risk

FEI: 3001269002 • Stockholm, Stockholms Lan • SWEDEN

FEI

FEI Number

3001269002

📍

Location

Stockholm, Stockholms Lan

🇸🇪

Country

SWEDEN
🏢

Address

Biovitrum Ab, Tomtebodavagen 23A. Solna, Stockholm, Stockholms Lan, Sweden

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/5/2002
Latest Refusal
7/5/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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
7/5/2002
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/5/2002
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/5/2002
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Swedish Orphan Biovitrum International AB's FDA import refusal history?

Swedish Orphan Biovitrum International AB (FEI: 3001269002) has 3 FDA import refusal record(s) in our database, spanning from 7/5/2002 to 7/5/2002.

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. Swedish Orphan Biovitrum International AB's FEI number is 3001269002.

What types of violations has Swedish Orphan Biovitrum International AB received?

Swedish Orphan Biovitrum International AB 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 Swedish Orphan Biovitrum International AB come from?

All FDA import refusal data for Swedish Orphan Biovitrum International AB 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.