FDA 483 OBSERVATION · #1835 OF 1,932 MOST-CITED
Results of testing
FDA cited this observation 6 times across 6 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
Failure to notify the donor of the results of tests for evidence of infection with relevant transfusion-transmitted infections that were a basis for deferral.
Failure to notify the donor of the results of further testing.
Failure to notify the donor of the results of tests for evidence of infection with relevant transfusion-transmitted infections that were a basis for deferral and further testing.
Failure to notify the donor of the results of tests for evidence of infection with relevant transfusion-transmitted infections that were a basis for deferral.
Failure to notify the donor of the results of tests for evidence of infection with relevant transfusion-transmitted infections that were a basis for deferral and further testing.
Failure to notify the donor of the results of tests for evidence of infection with relevant transfusion-transmitted infections that were a basis for deferral and further testing.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →