FDA Inspection
The Abraham J. And Phyllis Katz Cord BloodThe Abraham J. And Phyllis Katz Cord Blood – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns The Abraham J. And Phyllis Katz Cord Blood, with an inspection on September 15, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 15, 2023
- Product Type
- Biologics
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ID · f68405d9-5490-4ac1-a09b-480b6d3b87c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217939
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 600.12(a)Maintenance - concurrence
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 600.12(a)Maintenance - concurrence
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Other FDA inspections of The Abraham J. And Phyllis Katz Cord Blood
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 17, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 22, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Abraham J. And Phyllis Katz Cord Blood
- FDA Inspection 1336058 - 2026-09-11
- FDA Inspection 1115313 - 2020-01-17
- FDA Inspection 1051259 - 2018-03-22
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