FDA Inspection 912260 — Los Altos Surgery Center
The FDA completed an inspection of Los Altos Surgery Center on February 3, 2015 in Los Altos, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Los Altos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |