FDA 483 OBSERVATION · #40 OF 1,923 MOST-CITED
ELDU - producer causes Illegal drug residue
FDA cited this observation 567 times across 539 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 grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
A producer (typically of food animals) caused an illegal drug residue in edible tissues — for example through extralabel drug use that did not observe the extended withdrawal time, or use of a drug prohibited for extralabel use in food animals.
Why FDA writes it — Illegal drug residues in food-producing animals reach the human food supply. Extralabel use is permitted only under veterinary supervision with an extended withdrawal interval; a residue means that control failed, which FDA treats as a direct food-safety violation.
- Use drugs in food animals according to the label, or extralabel only under a valid veterinarian-client-patient relationship as AMDUCA permits.
- Observe the extended withdrawal time the veterinarian establishes for any extralabel use, to ensure residues deplete below tolerance.
- Do not use drugs prohibited from extralabel use in food-producing animals.
- Keep treatment and withdrawal records so residue-avoidance can be demonstrated.
- Extralabel use without observing the veterinarian-established extended withdrawal time.
- Poor treatment recordkeeping, so animals are sent to slaughter before residues deplete.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.7× the rate of the average FDA-cited firm (5.4% vs 7.8%), across 539 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
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
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. Open the 483 observation explorer →