FDA Inspection
BioStem Life SciencesBioStem Life Sciences – FDA Inspection, Jun 13, 2018
Record Details
This FDA Inspection record concerns BioStem Life Sciences, with an inspection on June 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 083c516d-ed06-4889-a482-5bcc6361e7fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055502
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.230(a)Validation & approval--established procedures
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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 | |
| September 15, 2023 | OAI | 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 1219616 - 2023-09-15
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