1Material and supplier control
Written standard operating procedures including all steps to be followed in the collection of blood and blood components for are not always maintained and followed.
Inspection Record
American Red Cross Greater Alleghenies Regio — FDA 483 Findings
Inspectors Travis R. Hunt · Marjorie L. DavisThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Deviation from the procedural requirements of a decree of injWlction.
3Material and supplier control
The personnel responsible for the collection of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent perfonnance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
4Deviation, CAPA, and investigation
A thorough investigation of each reported adverse reaction was not made.
5Quality unit oversight
Written procedures are not reviewed and approved by the quality control unit.
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.
