FDA Inspection 862242 — Stembanc Inc
The FDA completed an inspection of Stembanc Inc on February 12, 2014 in Chardon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chardon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12285 | 21 CFR 1271.80(a) | Birth mother sample not tested |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |