FDA Inspection 1117126 — Regenerative Biologics Inc.
The FDA completed an inspection of Regenerative Biologics Inc. on Feb 6, 2020 in Alachua, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 6, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |