FDA Inspection 1176417 — Vivex Biologics, Inc.
The FDA completed an inspection of Vivex Biologics, Inc. on August 4, 2022 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
- August 4, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12343 | 21 CFR 1271.190(a) | State of repair |