FDA Inspection 865516 — Nuvasive PR, Inc.
The FDA completed an inspection of Nuvasive PR, Inc. on February 11, 2014 in Guaynabo, PR. 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
- February 11, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Guaynabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12437 | 21 CFR 1271.270(a) | Records incomplete |