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Fresenius Kabi (Brunna Facility) AB

⚠️ Moderate Risk

FEI: 3002996654 • Kungsangen, Stockholms Lan • SWEDEN

FEI

FEI Number

3002996654

📍

Location

Kungsangen, Stockholms Lan

🇸🇪

Country

SWEDEN
🏢

Address

Kraftvagen 1, , Kungsangen, Stockholms Lan, Sweden

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
4/1/2014
Latest Refusal
4/1/2014
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

37611×

FILTH

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance

Refusal History

DateProductViolationsDivision
4/1/2014
65RDK27PROTEIN HYDROLYSATE (INJECTION) REPLENISHER
3761FILTH
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Fresenius Kabi (Brunna Facility) AB's FDA import refusal history?

Fresenius Kabi (Brunna Facility) AB (FEI: 3002996654) has 1 FDA import refusal record(s) in our database, spanning from 4/1/2014 to 4/1/2014.

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. Fresenius Kabi (Brunna Facility) AB's FEI number is 3002996654.

What types of violations has Fresenius Kabi (Brunna Facility) AB received?

Fresenius Kabi (Brunna Facility) 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 Fresenius Kabi (Brunna Facility) AB come from?

All FDA import refusal data for Fresenius Kabi (Brunna Facility) 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.