FDA 483 OBSERVATION · #698 OF 1,932 MOST-CITED
Donor screening standards
FDA cited this observation 30 times across 28 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
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents and clinical evidence of infection due to communicable disease agents.
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents.
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents and clinical evidence of infection due to communicable disease agents.
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of clinical evidence of infection due to communicable disease agents.
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents.
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →