1Training and personnel
Education and training of personnel as documented in the Learner Management System (LMS) is not accurate.
Inspection Record
American Red Cross Southeastern Michigan Region — FDA 483 Findings
Inspectors Barbara A. Rusin · L'Oreal D. Fowlkes · Sherri J. BlessmanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Written standard operating procedures including all steps to be followed in the collection, processing, storage, and distributio.n ofblood .
3Aseptic processing and sterility assurance
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood .
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.
