1Complaint and recall handling
Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall.
Inspection Record
American National Red Cross Heart of America Region — FDA 483 Findings
Inspectors Laurie A. HaxelThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The personnel responsible for the collection of blood or blood components are not adequate in number to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity a nd effectiveness it purports or is represented to possess.
3Other quality system
Failure to maintain general records.
4Deviation, CAPA, and investigation
A thorough investigation of each reported adverse reaction was not made.
5Material and supplier control
Written standard operating procedures including all steps to be followed in the collection and distribution of blood and blood components for homologous transfusion are not always maintained and followed.
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.
