1Quality unit oversight
Problem reports ha ve continued to be open due to Corrective Action Plan (CAP) rejec tion, resubmission , and/or delayed QA review.
Inspection Record
American Red Cross Southeastern Michigan Region — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Random platelet pools with positive bottle alarms are not always managed within a timely manner and accord ing to the appropriate standard operating procedur es.
3Training and personnel
As of June 18, 2008, there was no written documentation to support that nursing employees redacted (b)( 4) and redacted (b)(4) received training on Performing the Phys ical Exam for redacted (b)(4) Al logeneic/Directed and Autologous Apheresis Double Red Cell Donors prior to transferring from apheresis collections to whole blood collections in September 2007.
4Other quality system
Redacted (b)(4 ) addresses the performance of EC s as a measur e of corrective action effectiveness, provides guidelines as to the required frequency of ECs, in cluding sustained cor rective actions, and provides for establishment of due dates for ECs.
5Other quality system
Authorized curricula were no t always found to be signed and completed by the learner (staff) and the sup ervisor.
6Other quality system
The redacted (b)(4) indicates sampl ing strategies for several blood products.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
