FDA Inspection 809585 — Advanced Surgicare, LLC
The FDA completed an inspection of Advanced Surgicare, LLC on Dec 6, 2012 in Santa Clara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 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 |