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Swedish Herbal Institute AB

⚠️ Moderate Risk

FEI: 2000005284 • Goteborg, Vastra Gotalands Lan • SWEDEN

FEI

FEI Number

2000005284

📍

Location

Goteborg, Vastra Gotalands Lan

🇸🇪

Country

SWEDEN
🏢

Address

Viktor Rydbergsgatan 10, , Goteborg, Vastra Gotalands Lan, Sweden

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/14/2006
Latest Refusal
4/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
4/14/2006
54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Swedish Herbal Institute AB's FDA import refusal history?

Swedish Herbal Institute AB (FEI: 2000005284) has 1 FDA import refusal record(s) in our database, spanning from 4/14/2006 to 4/14/2006.

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 Herbal Institute AB's FEI number is 2000005284.

What types of violations has Swedish Herbal Institute AB received?

Swedish Herbal Institute 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 Herbal Institute AB come from?

All FDA import refusal data for Swedish Herbal Institute 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.