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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.4× the rate of the average FDA-cited firm (11.3% vs 8.3%), across 97 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
You administered a prohibited in an extralabel manner to food-producing animal(s).
You administered a prohibited drug in an extralabel manner to food-producing animal(s).
You administered a prohibited drug in an extralabel manner to a food-producing animal(s).
You administered a prohibited drug in an extralabel manner to food-producing animal(s).
You administered a prohibited drug in an extralabel manner to food-producing animal(s).
You administered a prohibited drug in an extralabel manner to food-producing animal(s).
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.
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.
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