FDA Inspection 710391 — Isto Biologics
The FDA completed an inspection of Isto Biologics on Feb 18, 2011 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12460 | 21 CFR 1271.320(c) | Review and evaluation, report to FDA |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |