FDA 483 OBSERVATION · #319 OF 1,000 MOST-CITED
Infection with communicable disease agents
FDA cited this observation 66 times across 54 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
Donors were not tested for evidence of infection with relevant communicable disease agents.
Donors were not tested for evidence of infection with relevant communicable disease agents.
Donors were not tested for evidence of infection with relevant communicable disease agents.
Donors were not tested for evidence of infection with relevant communicable disease agents.
Donors were not tested for evidence of infection with relevant communicable disease agents.
Donors were not tested for evidence of infection with relevant communicable disease agents.
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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