FDA Inspection
StemCyte, IncStemCyte, Inc – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns StemCyte, Inc, with an inspection on February 11, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- StemCyte, Inc
- Inspection Date
- February 11, 2010
- Product Type
- Biologics
View Company Profile
ID · 2097e50c-919e-462b-86be-7efda227177e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643295
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.180(a)Design adequate to bar spread of CD"s
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
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Other FDA inspections of StemCyte, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | Not classified | Los Angeles District Office | Human Cellular, Tissue, and Gene Therapies |
| July 31, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 12, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 28, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for StemCyte, Inc
- FDA Inspection 1291150 - 2026-03-24
- FDA Inspection 1101775 - 2019-07-31
- FDA Inspection 821099 - 2013-03-12
- FDA Inspection 736757 - 2011-07-28
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