FDA 483 OBSERVATION · #1233 OF 1,932 MOST-CITED
Eligibility statement--basis of determination
FDA cited this observation 12 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
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →