FDA Inspection 857702 — OneLegacy
The FDA completed an inspection of OneLegacy on December 5, 2013 in Orange, 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
- December 5, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orange, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12353 | 21 CFR 1271.190(d)(1) | Description of methods, schedule |