FDA 483 OBSERVATION · #397 OF 1,000 MOST-CITED
Accurate, indelible, legible
FDA cited this observation 49 times across 44 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 0.8× the rate of the average FDA-cited firm (6.8% vs 8.3%), across 44 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
Donor eligibility records are not accurate.
Donor eligibility records are not accurate.
Records were not accurate.
Records were not accurate.
Donor eligibility records are not accurate, indelible and legible.
Donor eligibility records are not accurate, indelible and legible.
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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