FDA Inspection 644680 — Genesis Biologics, Inc
The FDA completed an inspection of Genesis Biologics, Inc on Jan 27, 2010 in Newbury Park, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 27, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Newbury Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |