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Bio-Ag Consultants & Distributors Inc.

⚠️ Moderate Risk

FEI: 3004294586 • Wellesley, Ontario • CANADA

FEI

FEI Number

3004294586

📍

Location

Wellesley, Ontario

🇨🇦

Country

CANADA
🏢

Address

1400 Greenwood Hill, RR 3, Wellesley, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/25/2011
Latest Refusal
2/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
2/25/2011
68YDY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
238UNSAFE ADD
72NEW VET DR
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Bio-Ag Consultants & Distributors Inc.'s FDA import refusal history?

Bio-Ag Consultants & Distributors Inc. (FEI: 3004294586) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2011 to 2/25/2011.

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. Bio-Ag Consultants & Distributors Inc.'s FEI number is 3004294586.

What types of violations has Bio-Ag Consultants & Distributors Inc. received?

Bio-Ag Consultants & Distributors Inc. 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 Bio-Ag Consultants & Distributors Inc. come from?

All FDA import refusal data for Bio-Ag Consultants & Distributors 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.