1Other quality system
Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.
Inspection Record
B Positive National Blood Services - Wyoming, LLC. — FDA 483 Findings
Inspectors Michele GottshallThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Records are not made concurrently with the performance of each step in the distribution of products.
3Material and supplier control
Written standard operating procedures including all steps to be followed in the collection, processing, storage and distribution ofblood and blood components for further manufacturing purposes were not always established.
About this record
Extracted automatically from the document US FDA published on 2026-07-24. 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.
