Biomat USA, Inc.February 13, 2025

FDA 483 - Biomat USA, Inc. - February 13, 2025

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Record Details

An FDA inspection of Biomat USA, Inc. in Allentown, PA, conducted from February 10-13, 2025, identified a significant issue regarding phlebotomy site preparation. Specifically, a phlebotomist was observed palpating a venipuncture site without proper re-scrubbing, which could compromise the sterility of collected blood. This observation indicates a potential risk to donor safety and product quality.

Company: Biomat USA, Inc.
Inspection Date: February 13, 2025
Product Type: Biologics
Office: Philadelphia District Office
People: Matthew J. Gretkierewicz (issuing_officer)
Michele Gottshall

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ID · bb801b30-1b9a-4a23-a3ff-d2e1fa01382b