FDA 483 OBSERVATION · #209 OF 1,923 MOST-CITED
Individual identity of animal(s)
FDA cited this observation 141 times across 138 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 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 (7.2% vs 7.8%), across 138 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 keep records regarding the identity of and record the existing identification of the animal(s) that you purchased and transported and delivered for sale and consignment at a slaughter plant.
You did not identify, keep records regarding the identity of and record the existing identification of the animal(s) that you and delivered for sale at an auction barn.
You did not record the existing identification of the animal(s) that you and delivered for sale at an auction barn.
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.
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 →