1Other quality system
The Medical Director review was not completed on 3 Donor Reaction and Injury Reports (DRIRs) and it was completed over 3 weeks after the reaction on 9 others.
Inspection Record
American National Red Cross Indiana-Ohio Region — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
No defined process in bow test results are distributed and accounted for by the Charlotte, NC DCSC teams
3Other quality system
The "Final Quality Review" of the Donor Reaction and Injury Report was not performed on 11 of the 24 reactions an d was performed more than 2 months after the Medical Director Review on 4 occasions.
4Material and supplier control
The Process Verification signature was missing on 3 of the 4 available Component Status Change Records (CSCRs).
5Other quality system
The Process Verification signature in Section G was missing on 4 of the 5 available Donor Status Change Records (DSCRs).
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.
