The Abraham J. And Phyllis Katz Cord Blood – FDA 483, Jan 17, 2020
The Abraham J & Phyllis Katz Cord Blood Foundation in Cleveland, OH, a licensed cord blood bank, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production controls, inadequate investigation of discrepancies, insufficient microbial control procedures, and deficiencies in aseptic processing areas and equipment maintenance. The firm also failed to maintain reserve samples and lacked proper procedures for component approval and storage.
- Inspection date
- January 17, 2020
- Product type
- biologics
ID · 50703f79-cb2b-441a-9060-a1ebee9721a6
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