1Material and supplier control
Written standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
Inspection Record
Biomat USA Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Records fail to show test results so as to provide a complete history of the work performed.
3Other quality system
The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions.
About this record
Extracted automatically from the document US FDA published on 2026-07-14. 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.
