FDA 483 OBSERVATION · #277 OF 1,000 MOST-CITED
Prescribed ELDU - vet causes an illegal drug residue
FDA cited this observation 78 times across 77 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.
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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