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Andra

⚠️ Moderate Risk

FEI: 3010020778 • Reykjavik • ICELAND

FEI

FEI Number

3010020778

📍

Location

Reykjavik

🇮🇸

Country

ICELAND
🏢

Address

Skipholti 50d, , Reykjavik, , Iceland

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/19/2013
Latest Refusal
3/19/2013
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

751×

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
3/19/2013
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
335LACKS N/C
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Andra's FDA import refusal history?

Andra (FEI: 3010020778) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2013 to 3/19/2013.

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. Andra's FEI number is 3010020778.

What types of violations has Andra received?

Andra has been cited for 2 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 Andra come from?

All FDA import refusal data for Andra 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.