483
Biomat USA IncFDA 483 - Biomat USA Inc - April 14, 2026
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Record Details
An FDA inspection of Biomat USA Inc.'s source plasma establishment in Lufkin, TX, revealed significant deficiencies across four observations. The firm failed to properly present educational materials to donors, conduct thorough investigations into discrepancies, and maintain accurate donor and processing records. Additionally, employees did not consistently follow written standard operating procedures for blood collection and storage.
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