FDA 483 OBSERVATION · #356 OF 1,000 MOST-CITED
Eligibility not required--warning labels
FDA cited this observation 58 times across 51 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.
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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