1Deviation, CAPA, and investigation
The DCSC bas yet to implement an effective correction action associated with problems with the management of Iookback investigations that were discovered as far back as 3/15/10.
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
2Equipment and facility
The March 2009 BHQ audit of the Charlotte DCSC facility cited untimely management of problems.
3Deviation, CAPA, and investigation
Job Aid 11.4.ja0561 Timing Guidelines for Recipient Complication Investigations, requires that the DCSC complete a case investigation within three months of it being opened or document why the case remains open: In add JA 11.4.ja056 requires that REDACTION b(4) review of each opened case file be performed to ensure that actions are being appropriately managed.
4Equipment and facility
The October 2008 BHQ audit qf the Philadelphia DCSC facility cited the untimely management of problems.
5Other quality system
ARC has identified trends related to management of suspect blood products and inventory management, but has failed to promptly and thoroughly correct the problems.
6Other quality system
The Philadelphia DCSC has failed to follow ARC's Problem Management SOPs in that the problems associated the proper deferral of donors in the NDDR are not thoroughly investigated- For example, A.
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.
