1294104
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 5, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cedar Grove, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |