The Abraham J. And Phyllis Katz Cord Blood – FDA 483, Sep 15, 2023
An FDA inspection of Abraham J. and Phyllis Katz Cord Blood Foundation in Warrensville Heights, OH, revealed significant deficiencies across multiple areas of their operations. Observations included inadequate aseptic processing area cleaning and environmental monitoring practices, as well as failures in maintaining concurrent records. These issues indicate a lack of adherence to established procedures and good documentation practices, which are critical for ensuring the quality and safety of cord blood units.
- Inspection date
- September 15, 2023
- Product type
- biologics
ID · 6231d869-a0e6-4c0f-8a22-37066208ac5c
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