FDA 483 OBSERVATION · #420 OF 1,932 MOST-CITED
Responsible person to determine, document
FDA cited this observation 62 times across 53 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 2.7× the rate of the average FDA-cited firm (20.8% vs 7.8%), across 53 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 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 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.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →