FDA Inspection 659051 — Stembanc Inc
The FDA completed an inspection of Stembanc Inc on April 27, 2010 in Chardon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chardon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12291 | 21 CFR 1271.80(d)(2) | Plasma diluted test specimens |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |