FDA Inspection
StemCyte, IncStemCyte, Inc – FDA Inspection, Mar 24, 2026
Record Details
This FDA Inspection record concerns StemCyte, Inc, with an inspection on March 24, 2026, issued by the Los Angeles District Office, covering biologics.
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ID · fe5f8458-e932-47ff-a32a-9ff2060b47b0
Inspection Facts
- Inspection number
- 1291150
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of StemCyte, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 11, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for StemCyte, Inc
- FDA Inspection 1101775 - 2019-07-31
- FDA Inspection 821099 - 2013-03-12
- FDA Inspection 736757 - 2011-07-28
- FDA Inspection 643295 - 2010-02-11
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