FDA 483 OBSERVATION · #729 OF 1,932 MOST-CITED
SOP for release; reactive for CMV
FDA cited this observation 28 times across 27 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 grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
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, maintained, defined, documented, implemented and followed.
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.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →