FDA Inspection 951971 — Vivex Biologics, Inc.
The FDA completed an inspection of Vivex Biologics, Inc. on December 18, 2015 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |