FDA Inspection 745694 — GCAM Inc
The FDA completed an inspection of GCAM Inc on September 22, 2011 in Moreno Valley, 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
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Moreno Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9315 | 21 CFR 640.65(b)(3) | Donor identification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |