FDA 483 OBSERVATION · #1183 OF 1,932 MOST-CITED
Abbreviated procedure
FDA cited this observation 13 times across 12 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
The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
The abbreviated donor screening procedure did not determine and document changes in the donor's medical history that would make the donor ineligible.
The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
The abbreviated donor screening procedure did not determine and document changes in the donor's medical history that would make the donor ineligible.
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 →