← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #231 OF 1,000 MOST-CITED

Drugs prohibited for extralabel use in food-producing animal(s)

FDA cited this observation 100 times across 97 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

BY PROGRAM AREA
Veterinary Medicine100
BY FISCAL YEAR
FY20264
FY202515
FY20242
FY20235
FY202212
FY20204
FY201915
FY201825
FY201718

How FDA worded it — real examples

You administered a prohibited in an extralabel manner to food-producing animal(s).

WAKKER DAIRY FARM LLC · Kewaunee, Wisconsin · Veterinary Medicine · 2026-01-29

You administered a prohibited drug in an extralabel manner to food-producing animal(s).

Tony L. Lopes Dairy L.P. · Gustine, California · Veterinary Medicine · 2025-12-02

You administered a prohibited drug in an extralabel manner to a food-producing animal(s).

Windmill Dairy · Florence, Arizona · Veterinary Medicine · 2025-11-07

You administered a prohibited drug in an extralabel manner to food-producing animal(s).

Brearley Farms, Inc. · Portland, Michigan · Veterinary Medicine · 2025-10-30

You administered a prohibited drug in an extralabel manner to food-producing animal(s).

Frank Gwerder Dairy Inc. · Modesto, California · Veterinary Medicine · 2025-09-10

You administered a prohibited drug in an extralabel manner to food-producing animal(s).

Jackson Dairy LLC · Hanford, California · Veterinary Medicine · 2025-09-04

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

Veterinary industry

Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →