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Larrea Rx Inc

⚠️ Moderate Risk

FEI: 3004110962 • Vancouver, BC • CANADA

FEI

FEI Number

3004110962

📍

Location

Vancouver, BC

🇨🇦

Country

CANADA
🏢

Address

400-55 Water St, , Vancouver, BC, Canada

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/25/2003
Latest Refusal
9/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4821×

NUTRIT LBL

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 fails to bear the required nutrition information.

4881×

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.

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
9/25/2003
62VAE99ANTI-VIRAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/21/2003
54ABY99VITAMIN, N.E.C.
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Larrea Rx Inc's FDA import refusal history?

Larrea Rx Inc (FEI: 3004110962) has 2 FDA import refusal record(s) in our database, spanning from 9/21/2003 to 9/25/2003.

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. Larrea Rx Inc's FEI number is 3004110962.

What types of violations has Larrea Rx Inc received?

Larrea Rx Inc has been cited for 3 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 Larrea Rx Inc come from?

All FDA import refusal data for Larrea Rx Inc 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.