FDA Inspection 621635 — Vivex Biologics, Inc.
The FDA completed an inspection of Vivex Biologics, Inc. on October 2, 2009 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 2, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12395 | 21 CFR 1271.225 | Verification/validation |