FDA Inspection 754077 — Hitachi Aloka Medical, Ltd.
The FDA completed an inspection of Hitachi Aloka Medical, Ltd. on Nov 16, 2011 in Wallingford, CT. 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
- Nov 16, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wallingford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |