FDA 483 OBSERVATION · #413 OF 1,000 MOST-CITED
Responsible person to determine, document
FDA cited this observation 48 times across 40 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 2.7× the rate of the average FDA-cited firm (22.5% vs 8.3%), across 40 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
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
The eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
The eligibility of an HCT/P donor was not by a responsible person, based on results of donor screening and donor testing.
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
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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