Company
JapanElltec Co., Ltd., Nagoya, Japan – FDA Inspections
Inspection records and compliance data for Elltec Co., Ltd. in Nagoya. 1 FDA inspection on record, last inspected August 12, 2010.
Company Profile
This profile covers Elltec Co., Ltd. based in Nagoya, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected August 12, 2010.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 12, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 679349 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Elltec Co., Ltd.
FEI Number
3002788813
Address
2 Chome 18-5 Shirakawa No. 6 Bldg., Nishiki; Naka, Nagoya, Japan
Country
Japan
ID: 2bfb2bee-947b-44e0-a7d3-18cbcce5dadc