FDA 483 OBSERVATION · #1597 OF 1,918 MOST-CITED
Donor's Acknowledgment - Exculpatory language
FDA cited this observation 7 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
The donor acknowledgment did not address donors receipt and review of information regarding risks and hazards of the specific donation procedure.
The donor acknowledgment did not address donors receipt and review of information regarding risks and hazards of the specific donation procedure and did not address an opportunity for the donor to ask question and withdraw from the donation procedure.
The donor acknowledgment did not address the donor's record with identification of the donor as ineligible to donate and did not address donors receipt and review of information regarding risks and hazards of the specific donation procedure.
The donor acknowledgment contained exculpatory language through which the donor is made to waive or appear to waive any of the donor’s legal rights, did not address the donor’s review of educational material regarding relevant transfusion-transmitted infections, did not address the donor’s agreement to not donate if the donation could result in a potential risk to recipients and did not address donors receipt and review of information regarding risks and hazards of the specific donation procedure.
The donor acknowledgment did not address donor notification of the basis for deferral and the period of deferral.
The donor acknowledgment did not address the donor’s review of educational material regarding relevant transfusion-transmitted infections, did not address the donor’s agreement to not donate if the donation could result in a potential risk to recipients and did not address an opportunity for the donor to ask question and withdraw from the donation procedure.
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 →