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.
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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