FDA Inspection
BioStem Life SciencesBioStem Life Sciences – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns BioStem Life Sciences, with an inspection on September 15, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · de55e7e3-8385-47a6-a7e2-115a7f378976
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1219616
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of BioStem Life Sciences
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | Not classified | Florida District Office | |
| June 13, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for BioStem Life Sciences
- FDA Inspection 1291328 - 2025-09-26
- FDA Inspection 1055502 - 2018-06-13
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