1Other quality system
The DCSC does not always meet the established timeframes required in the System 10 Problem Management Procedures and in the Decree.
Inspection Record
American Red Cross - Donor and Client Support Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The DCSC failed to ensure timely and accurate management of DRIRs.
3Other quality system
ARC has identified trends related to DRIRs beginning in 6/09, but has failed to promptly and thoroughly correct and prevent recurrence ofDRIR documentation problems.
4Quality unit oversight
Quality Assurance (QA) at the DCSC: ARC has failed to follow Paragraph IV.A.2.a.
5Deviation, CAPA, and investigation
The DCSC has yet to implement an effective correction action associated with problems with the management of lookback investigations t.h3t were discovered as far back as 3/15/10.
6Other quality system
ARC has identified trends related to management of confmnatory test results and DDR entry, but has failed to tpromptly and thoroughly investigate, correct, and prevent the problems.
7Equipment and facility
The March 2009 BHQ audit ofthe Charlotte DCSC facility cited untimely management of problems.
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.
