FDA Inspection
StemCyte, IncStemCyte, Inc – FDA Inspection, Mar 12, 2013
Record Details
This FDA Inspection record concerns StemCyte, Inc, with an inspection on March 12, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- StemCyte, Inc
- Inspection Date
- March 12, 2013
- Product Type
- Biologics
View Company Profile
ID · 9e207d14-46c2-4b4c-88d8-ef7c1db86ae9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821099
- 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 1271.195(a)(2)Ventilation and air filtration controls
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.190(b)(2)Sewage, trash removal
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
Full citation text and observation details available on the Dashboard.
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 |
| 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 1291150 - 2026-03-24
- FDA Inspection 1101775 - 2019-07-31
- FDA Inspection 736757 - 2011-07-28
- FDA Inspection 643295 - 2010-02-11
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