FDA Inspection 895069 — Celebration Stem Cell Centre LLC
The FDA completed an inspection of Celebration Stem Cell Centre LLC on August 15, 2014 in Gilbert, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gilbert, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |