FDA 483 OBSERVATION · #1253 OF 1,932 MOST-CITED
Additional Medical Assessment Factors
FDA cited this observation 11 times across 11 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
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by symptoms of a recent or current illness.
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by travel to, or residence in, an area endemic for a transfusion-transmitted infection.
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by.
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by symptoms of a recent or current illness and certain medical treatments or medications.
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by symptoms of a recent or current illness.
Medical history assessment failed to include factors that make the donor ineligible to donate when donating could adversely affect the health of the donor or the safety, purity, or potency of the blood or blood component could be affected adversely by exposure or possible exposure to an accidentally or intentionally released disease or disease agent relating to a transfusion-transmitted infection.
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 →