FDA Inspection 596205 — Stembanc Inc
The FDA completed an inspection of Stembanc Inc on August 31, 2009 in Chardon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chardon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12285 | 21 CFR 1271.80(a) | Birth mother sample not tested |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |