FDA 483 OBSERVATION · #275 OF 1,000 MOST-CITED
Prescribed ELDU - vet causes an illegal drug residue
FDA cited this observation 106 times across 104 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 1.5× the rate of the average FDA-cited firm (11.5% vs 7.7%), across 104 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 caused an illegal residue in a food-producing animal of an approved human or animal drug through using the drug contrary to its labeling, and did not take appropriate measures to assure that no illegal residue would occur.
You caused an illegal residue in a food-producing animal of an approved human or animal drug through prescribing the use of the drug contrary to its labeling, and did not take appropriate measures to assure that no illegal residue would occur.
You caused an illegal residue in a food-producing animal of an approved human or animal drug through using the drug contrary to its labeling, and did not take appropriate measures to assure that no illegal residue would occur.
Causing an illegal residue in a food-producing animal of an approved human or animal drug through using the drug contrary to its labeling, and failing to take appropriate measures to assure that no illegal residue would occur.
Causing an illegal residue in a food-producing animal of an approved human or animal drug through using the drug contrary to its labeling, and failing to take appropriate measures to assure that assigned timeframes for withdrawal were met and no illegal residue would occur.
Causing an illegal residue in a food-producing animal of an approved human or animal drug through using the drug contrary to its labeling, and failing to take appropriate measures to assure that no illegal residue would occur.
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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