FDA Inspection 643295 — StemCyte, Inc
The FDA completed an inspection of StemCyte, Inc on February 11, 2010 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
- February 11, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Baldwin Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |