483
Octapharma Plasma, Inc.FDA 483 - Octapharma Plasma, Inc. - December 20, 2024
Discuss this record with AI
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.
Record Details
An FDA inspection of Octapharma Plasma, Inc. in Terre Haute, IN, a source plasma center, identified a critical failure in aseptic technique during blood collection. A phlebotomist was observed contaminating a donor's venipuncture site by palpating it with a gloved hand after sterilization. This lapse posed an imminent hazard and required immediate intervention.
Open in Dashboard
ID · 797d1e89-8543-4016-9de0-879a663c6e72