Findings
1Other quality system
Failure to ensure procedures are in compliance with the donor eligibility requirements within Subpart C – Donor Eligibility of 21 CFR 1271 [21 CFR 1271.47(a)]. For example, your procedure, “SOP-DC-1, Transplant Tissue Exclusionary Criteria” (Revision 15, Implementation Date 11/29/22), used to determine donor eligibility and “Form F-DC-25 Sepsis Consult Flowchart” (Revision 1, Implementation Date 03/14/19), used to determine if an infectious disease consult is required, fail…
2Other quality system
In response to Observation 1, your disagreement that the donors were septic at the time of death does not account for the donors’ medical records with documented diagnoses and clinical evidence of sepsis, including systemic responses to infection, during their hospital stay immediately preceding death. Your response states, “there is still only one gold standard for the diagnosis of sepsis, and that is a positive blood culture” and that the blood cultures were negative, and…
3Other quality system
Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1) [21 CFR 1271.75(d)]. Between January 2021 and January 2024, you failed to determine as ineligible five donors of ocular HCT/Ps with a documented diagnosis or clinical evidence of sepsis, including two or more systemic responses to infection…
About this record
Extracted automatically from the document US FDA published on 2024-06-25. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
