1Deviation, CAPA, and investigation
Deviation from the procedural requirements of a decree of injunction.
Inspection Record
American Red Cross Blood Services — FDA 483 Findings
Inspectors Anthony N Onianwa · Alice C. SilvaThe 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
Written records are not always made of investigations into unexplained discrepancies.
3Material and supplier control
The personnel responsible for the collection of blood or blood components are not adequate in number to assure competent performence of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports ot is represented to possess.
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.
