809585
Advanced Surgicare, LLC — FEI 3006722019
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12460 | 21 CFR 1271.320(c) | Review and evaluation, report to FDA |