Company
JapanDenka Co. Ltd., Gosen, Japan – FDA Inspections
Inspection records and compliance data for Denka Co. Ltd. in Gosen. 2 FDA inspections on record, 1 Form 483, last inspected May 23, 2024.
Company Profile
This profile covers Denka Co. Ltd. based in Gosen, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 6, 2017. Last inspected May 23, 2024.
Most cited issue areas
- Design input - documentation1 inspection
- Lack of or inadequate procedures1 inspection
- Sampling plans1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 23, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1241642 |
| July 6, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1022352 |
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 Co. Ltd.
FEI Number
3003871639
Address
1359-1, Minamihon-Cho, Gosen, Japan
Country
Japan
ID: 2a37bc8b-6daa-40d8-a78f-2f2a6a419c40