FDA 483 OBSERVATION · #731 OF 1,932 MOST-CITED
Reasons for ineligibility on summary
FDA cited this observation 28 times across 26 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 summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →