# FDA 483 - Abraham J. and Phyllis Katz Cord Blood Foundation - January 17, 2020

Source: https://www.keypedia.com/records/483/abraham-j-and-phyllis-katz-cord-blood-foundation/50703f79-cb2b-441a-9060-a1ebee9721a6

> FDA 483 for Abraham J. and Phyllis Katz Cord Blood Foundation on January 17, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abraham J. and Phyllis Katz Cord Blood Foundation
- Inspection Date: 2020-01-17
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: 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.

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## Related Officers

- [Regulatory Project Manager](https://www.keypedia.com/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

Company: https://www.keypedia.com/companies/abraham-j-and-phyllis-katz-cord-blood-foundation/2665cdeb-06d3-4c71-8c69-e14cc4c81536

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22