FDA Inspection
Cord for Life, Inc.Cord for Life, Inc. – FDA Inspection, Jun 10, 2026
Record Details
This FDA Inspection record concerns Cord for Life, Inc., with an inspection on June 10, 2026, issued by the Florida District Office, covering biologics.
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ID · 3b34995c-cb97-4b7f-bab4-46fdea456415
Inspection Facts
- Inspection number
- 1321378
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.42(c)(10)(v)Cleaning System
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cord for Life, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 30, 2018 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 21, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cord for Life, Inc.
- FDA Inspection 1149863 - 2021-08-26
- FDA Inspection 1073266 - 2018-11-30
- FDA Inspection 1002027 - 2017-01-13
- FDA Inspection 923079 - 2015-04-21
- FDA Inspection 770230 - 2012-02-28
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