483
INCELL Corporation LLCINCELL Corporation LLC – FDA 483, Sep 29, 2023
Record Details
INCELL Corporation LLC in San Antonio, TX, was inspected regarding its HCT/P manufacturing. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, product testing, and stability data for its amniotic fluid-derived injectable products. These issues indicate a lack of robust controls to ensure product sterility, identity, and appropriate expiration dating.
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ID · b63b0e6b-4002-4d92-b490-42e1775f7e71
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