483
Biomat USA IncBiomat USA Inc – FDA 483, Feb 4, 2026
Record Details
An FDA inspection of Biomat USA Inc.'s Source Plasmapheresis Collection Center in Surprise, AZ, revealed significant deficiencies. Observations included a failure to maintain complete donor test records, non-adherence to standard operating procedures for donor arm preparation, and an inadequate SOP for investigating adverse donor reactions. These issues highlight concerns regarding data integrity, procedural compliance, and donor safety.
- Office
- Denver District Office
- Person
View Company Profile
ID · d09ce8cc-6192-4ea1-a948-01d2db55adb6
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.