FDA Inspection 917272 — Resonance Technology Inc
The FDA completed an inspection of Resonance Technology Inc on February 20, 2015 in Northridge, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northridge, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |