FDA Inspection 1258967 — Vital Orthopedics, LLC
The FDA completed an inspection of Vital Orthopedics, LLC on January 23, 2025 in Anaheim, CA. 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
- January 23, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |