FDA 483 OBSERVATION · #608 OF 1,000 MOST-CITED
Records not made readily available to FDA
FDA cited this observation 37 times across 36 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 4.3× the rate of the average FDA-cited firm (33.3% vs 7.7%), across 36 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
Records associated with drug product components, containers, closures, labeling, control and distribution and within the retention period for such records, were not made readily available for authorized inspection.
Records associated with drug product control and within the retention period for such records, were not made readily available for authorized inspection.
Records associated with drug product distribution and within the retention period for such records, were not made readily available for authorized inspection.
Records associated with drug product components, production and control and within the retention period for such records, were not made readily available for authorized inspection.
Records associated with drug product production and distribution and within the retention period for such records, were not made readily available for authorized inspection.
Records associated with drug product production and within the retention period for such records, were not made readily available for authorized inspection.
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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