FDA Inspection 1088972 — Nihon Kohden America LLC
The FDA completed an inspection of Nihon Kohden America LLC on April 30, 2019 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |