FDA 483 - Vitae Enim Vitae Scientific, Inc. - January 07, 2025
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Vitae Enim Vitae Scientific, Inc., a sterile injectable drug manufacturer in San Diego, CA, was cited for significant deficiencies during an FDA inspection from November 2024 to January 2025. The observations primarily concern inadequate environmental monitoring, poor quality control procedures for change management, and insufficient cleaning and sterilization validation in aseptic processing areas. The firm also failed to adequately investigate discrepancies and establish production phase time limits.
ID · 602ce8d0-befc-45cd-ba66-b2085a7e4b0e