483
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA 483, Dec 20, 2024
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.
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ID · 797d1e89-8543-4016-9de0-879a663c6e72
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