FDA 483 OBSERVATION · #1766 OF 1,918 MOST-CITED
Ineligible Donor
FDA cited this observation 5 times across 5 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
Blood or blood components were collected from a donor found to be deferred under the regulations prior to collection.
Blood or blood components were collected from a donor found to be ineligible prior to collection based on the regulations.
Blood or blood components were collected from a donor found to be ineligible prior to collection based on the regulations.
Blood or blood components were collected from a donor found to be ineligible prior to collection based on the regulations and found to be deferred under the regulations prior to collection.
Blood or blood components were collected from a donor found to be ineligible prior to collection based on the regulations.
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 →