FDA Inspection 814359 — Stembanc Inc
The FDA completed an inspection of Stembanc Inc on February 4, 2013 in Chardon, OH. 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 4, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chardon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12285 | 21 CFR 1271.80(a) | Birth mother sample not tested |
| 12408 | 21 CFR 1271.250(c) | All labeling requirements met |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |