483
Biomat USA, Inc.FDA 483 - Biomat USA, Inc. - February 13, 2025
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An FDA inspection of Biomat USA, Inc. in Allentown, PA, a source plasma donor center, revealed one observation related to inadequate phlebotomy site preparation. Specifically, a phlebotomist was observed palpating a venipuncture site after initial preparation without re-scrubbing, which could compromise the sterility of the blood collection.
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ID · ddc8099f-7cc2-449d-ac4e-e790688a2bd2