Company
JapanDenka Seiken Co., Ltd. - Niigata Factory, Gosen, Japan – FDA Inspections
Inspection records and compliance data for Denka Seiken Co., Ltd. - Niigata Factory in Gosen. 1 FDA inspection on record, last inspected February 13, 2014.
Company Profile
This profile covers Denka Seiken Co., Ltd. - Niigata Factory based in Gosen, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected February 13, 2014.
Most cited issue areas
- Design input - documentation1 inspection
- Design output - Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868473 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Denka Seiken Co., Ltd. - Niigata Factory
FEI Number
3003927438
Address
Denkaseiken (Kabu) Niigatakojo, 1 Chome 1 Chome Goshen-Shi, Niigata, 959-1695 Japan; Minamihon-Cho; Minamihon-Cho, Gosen, Japan
Country
Japan
ID: 58990739-9318-428f-9454-5b515d49cb53