FDA 483 OBSERVATION · #925 OF 1,000 MOST-CITED
Kits not FDA approved, specifically labeled
FDA cited this observation 19 times across 17 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
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
Communicable disease agent tests were not FDA-licensed, approved or cleared donor screening tests.
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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