FDA Inspection 634812 — JVC KENWOOD Corporation
The FDA completed an inspection of JVC KENWOOD Corporation on Oct 29, 2009 in Yokohama-shi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 29, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yokohama-shi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3413 | 21 CFR 820.200(d)(5) | Service performed |