FDA Inspection
Hitachi Aloka Medical, Ltd.Hitachi Aloka Medical, Ltd. – FDA Inspection, Nov 16, 2011
Record Details
This FDA Inspection record concerns Hitachi Aloka Medical, Ltd., with an inspection on November 16, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hitachi Aloka Medical, Ltd.
- Inspection Date
- November 16, 2011
- Product Type
- Devices
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ID · 9fd698a4-935c-427d-9efc-6373ff90bdd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754077
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.181(a)DMR device specifications
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Other FDA inspections of Hitachi Aloka Medical, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hitachi Aloka Medical, Ltd.
- FDA Inspection 864939 - 2014-01-24
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