FDA 483 OBSERVATION · #752 OF 1,000 MOST-CITED
SOP for release; reactive for CMV
FDA cited this observation 21 times across 21 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
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established and maintained.
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established, defined, documented and implemented.
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not maintained, defined and documented.
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
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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