FDA 483 OBSERVATION · #408 OF 1,000 MOST-CITED
Eligibility not required--warning labels
FDA cited this observation 62 times across 54 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 1.9× the rate of the average FDA-cited firm (14.8% vs 7.7%), across 54 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
HCT/Ps for which the donor eligibility determination was not required were not prominently labeled with the appropriate warning statements.
HCT/Ps for which the donor eligibility determination was not required were not prominently labeled with the appropriate warning statements.
HCT/Ps for which the applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.
HCT/Ps for which the donor eligibility determination was not required and applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.
HCT/Ps for which the donor eligibility determination was not required and applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.
HCT/Ps for which the donor eligibility determination was not required and applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.
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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