FDA Inspection 1063851 — Arthrex Inland Empire
The FDA completed an inspection of Arthrex Inland Empire on August 24, 2018 in Corona, CA. 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
- August 24, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |