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Biomed

⚠️ Moderate Risk

FEI: 3002083296 • Burnaby, BC • CANADA

FEI

FEI Number

3002083296

📍

Location

Burnaby, BC

🇨🇦

Country

CANADA
🏢

Address

3430 Brighton Ave, , Burnaby, BC, Canada

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
4/22/2003
Latest Refusal
11/25/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
4/22/2003
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
483DRUG NAME
New Orleans District Office (NOL-DO)
11/25/2002
62UBL99ANTI-TUSSIVE/COLD N.E.C.
331DR QUALITC
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Biomed's FDA import refusal history?

Biomed (FEI: 3002083296) has 2 FDA import refusal record(s) in our database, spanning from 11/25/2002 to 4/22/2003.

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. Biomed's FEI number is 3002083296.

What types of violations has Biomed received?

Biomed 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 Biomed come from?

All FDA import refusal data for Biomed 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.