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Sagamedica

⚠️ Moderate Risk

FEI: 3008591126 • Reykjavik • ICELAND

FEI

FEI Number

3008591126

📍

Location

Reykjavik

🇮🇸

Country

ICELAND
🏢

Address

Vatnagardar 16-18, , Reykjavik, , Iceland

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
1/25/2012
Latest Refusal
1/25/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4884×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
1/25/2012
54FYY03ANGELICA (HERBAL & BOTANICALS, NOT TEAS)
488HEALTH C
Cincinnati District Office (CIN-DO)
1/25/2012
54FYY03ANGELICA (HERBAL & BOTANICALS, NOT TEAS)
488HEALTH C
Cincinnati District Office (CIN-DO)
1/25/2012
54FYY03ANGELICA (HERBAL & BOTANICALS, NOT TEAS)
488HEALTH C
Cincinnati District Office (CIN-DO)
1/25/2012
54FYY03ANGELICA (HERBAL & BOTANICALS, NOT TEAS)
488HEALTH C
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sagamedica's FDA import refusal history?

Sagamedica (FEI: 3008591126) has 4 FDA import refusal record(s) in our database, spanning from 1/25/2012 to 1/25/2012.

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. Sagamedica's FEI number is 3008591126.

What types of violations has Sagamedica received?

Sagamedica 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 Sagamedica come from?

All FDA import refusal data for Sagamedica 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.