FDA 483 OBSERVATION · #1796 OF 1,918 MOST-CITED
Medical History Interview
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
Failure to conduct a medical history interview prior to collection of blood or blood components to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection.
Failure to conduct a medical history interview prior to collection of blood or blood components to determine if there are other conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood or blood components or any product manufactured from the blood or blood components.
Failure to conduct a medical history interview prior to collection of blood or blood components to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection and to determine if there are other conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood or blood components or any product manufactured from the blood or blood components.
Failure to conduct a medical history interview prior to collection of blood or blood components to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection and to determine if there are other conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood or blood components or any product manufactured from the blood or blood components.
Failure to conduct a medical history interview prior to collection of blood or blood components to determine if the donor is in good health, to identify risk factors closely associated with exposure to, or clinical evidence of, a relevant transfusion-transmitted infection and to determine if there are other conditions that may adversely affect the health of the donor or the safety, purity, or potency or the blood or blood components or any product manufactured from the blood or blood components.
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 →