INCELL Corporation LLCSeptember 29, 2023

FDA 483 - INCELL Corporation LLC - September 29, 2023

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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.

Company: INCELL Corporation LLC
Inspection Date: September 29, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
People: Bobbi Miller
Richard T. Riggie (investigator)

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ID · b63b0e6b-4002-4d92-b490-42e1775f7e71