Company
United StatesHitachi Aloka Medical, Ltd., Wallingford, CT – FDA Inspections
Inspection records and compliance data for Hitachi Aloka Medical, Ltd. in Wallingford, Connecticut. 2 FDA inspections on record, last inspected January 24, 2014.
Company Profile
This profile covers Hitachi Aloka Medical, Ltd. based in Wallingford, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected November 16, 2011. Last inspected January 24, 2014.
Most cited issue areas
- DHR content1 inspection
- DMR device specifications1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 864939 |
| November 16, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 754077 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hitachi Aloka Medical, Ltd.
FEI Number
1000120865
Address
10 Fairfield Blvd, Wallingford, Connecticut 06492, United States
Country
United States
ID: 1a7671ee-c67e-40e1-878f-82ddb36c4251