FDA Inspection 1016973 — Vivex Biologics, Inc.
The FDA completed an inspection of Vivex Biologics, Inc. on July 6, 2017 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |