FDA Inspection
The Abraham J. And Phyllis Katz Cord BloodThe Abraham J. And Phyllis Katz Cord Blood – FDA Inspection, Jan 17, 2020
Record Details
This FDA Inspection record concerns The Abraham J. And Phyllis Katz Cord Blood, with an inspection on January 17, 2020, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 17, 2020
- Product Type
- Biologics
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ID · d76aa79a-36b3-4d26-9ef0-3ee486f379d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115313
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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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 |
| September 15, 2023 | 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 1217939 - 2023-09-15
- FDA Inspection 1051259 - 2018-03-22
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