FDA Inspection 864939 — Hitachi Aloka Medical, Ltd.
The FDA completed an inspection of Hitachi Aloka Medical, Ltd. on Jan 24, 2014 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wallingford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |