FDA 483 OBSERVATION · #13 OF 1,000 MOST-CITED
Investigations of discrepancies, failures
FDA cited this observation 939 times across 788 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 4.4× the rate of the average FDA-cited firm (33.8% vs 7.7%), across 788 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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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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