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Wyeth Animal Health

⚠️ Moderate Risk

FEI: 3003921904 • Guelph, ON • CANADA

FEI

FEI Number

3003921904

📍

Location

Guelph, ON

🇨🇦

Country

CANADA
🏢

Address

400 Michener Rd, , Guelph, ON, Canada

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
10/27/2011
Latest Refusal
5/25/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.7×10%
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

33801×

EXPIRED

the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.

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).

821×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

Refusal History

DateProductViolationsDivision
10/27/2011
68FDY02HORSES HORMONES
3380EXPIRED
82RX LEGEND
New Orleans District Office (NOL-DO)
5/25/2006
62GQL99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wyeth Animal Health's FDA import refusal history?

Wyeth Animal Health (FEI: 3003921904) has 2 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 10/27/2011.

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. Wyeth Animal Health's FEI number is 3003921904.

What types of violations has Wyeth Animal Health received?

Wyeth Animal Health 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 Wyeth Animal Health come from?

All FDA import refusal data for Wyeth Animal Health 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.