FDA 483 OBSERVATION · #792 OF 1,000 MOST-CITED
Completion of eligibility determination
FDA cited this observation 19 times across 18 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 were not kept in quarantine until completion of the donor-eligibility determination.
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.
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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