FDA Inspection 821099 — StemCyte, Inc
The FDA completed an inspection of StemCyte, Inc on March 12, 2013 in Baldwin Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Baldwin Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12346 | 21 CFR 1271.190(b)(2) | Sewage, trash removal |
| 12358 | 21 CFR 1271.195(a)(2) | Ventilation and air filtration controls |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |