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Masi Bardi

⚠️ Moderate Risk

FEI: 3012002329 • Vancouver, British Columbia • CANADA

FEI

FEI Number

3012002329

📍

Location

Vancouver, British Columbia

🇨🇦

Country

CANADA
🏢

Address

4677 9th Ave W, , Vancouver, British Columbia, Canada

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
4/22/2016
Latest Refusal
4/22/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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
4/22/2016
31PGH99TEA SUBSTITUTES, N.E.C.
16DIRECTIONS
473LABELING
482NUTRIT LBL
488HEALTH C
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Masi Bardi's FDA import refusal history?

Masi Bardi (FEI: 3012002329) has 1 FDA import refusal record(s) in our database, spanning from 4/22/2016 to 4/22/2016.

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. Masi Bardi's FEI number is 3012002329.

What types of violations has Masi Bardi received?

Masi Bardi has been cited for 5 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 Masi Bardi come from?

All FDA import refusal data for Masi Bardi 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.