FDA Inspection
Stem Cell Cryo Bank, LLC / SFBMSCTIStem Cell Cryo Bank, LLC / SFBMSCTI – FDA Inspection, May 1, 2025
Record Details
This FDA Inspection record concerns Stem Cell Cryo Bank, LLC / SFBMSCTI, with an inspection on May 1, 2025, issued by the Florida District Office, covering biologics.
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ID · 9e9dbae4-61ca-48ab-a794-845f619d71dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269548
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stem Cell Cryo Bank, LLC / SFBMSCTI
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 2, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 7, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 18, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stem Cell Cryo Bank, LLC / SFBMSCTI
- FDA Inspection 1147032 - 2021-07-21
- FDA Inspection 1028953 - 2017-08-02
- FDA Inspection 766962 - 2012-02-07
- FDA Inspection 590673 - 2009-06-18
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