FDA Inspection 1095130 — North Florida Reproductive Biology Laboratory
The FDA completed an inspection of North Florida Reproductive Biology Laboratory on June 28, 2019 in Jacksonville, 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
- June 28, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12278 | 21 CFR 1271.75(a)(2) | Risks associated with xenotransplantation |