FDA Inspection 1215894 — Virak Orthopedics LLC
The FDA completed an inspection of Virak Orthopedics LLC on August 25, 2023 in Madison, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 25, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Madison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |