FDA 483 OBSERVATION · #213 OF 1,000 MOST-CITED
Individual identity of animal(s)
FDA cited this observation 138 times across 135 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 0.9× the rate of the average FDA-cited firm (6.7% vs 7.7%), across 135 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 did not identify and record the existing identification of the animal(s) that you purchased and transported and delivered for consignment at a slaughter plant.
You did not identify and keep records regarding the identity of the animal(s) that you transported and delivered for consignment at a slaughter plant.
You did not keep records regarding the identity of the animal(s) that you transported and delivered for sale at an auction barn.
You did not keep records regarding the identity of the animal(s) that you purchased and delivered for consignment at an auction barn.
You did not identify, keep records regarding the identity of and record the existing identification of the animal(s) that you transported and delivered for sale at an auction barn.
You did not keep records regarding the identity of the animal(s) that you transported and delivered for sale at an auction barn.
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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