Company
JapanKaneka Corporation, Settsu, Japan – FDA Inspections
Inspection records and compliance data for Kaneka Corporation in Settsu. 4 FDA inspections on record, 1 Form 483, last inspected February 06, 2025.
Company Profile
This profile covers Kaneka Corporation based in Settsu, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected September 13, 2012. Last inspected February 6, 2025.
Most cited issue areas
- Evaluation, timeliness, identification1 inspection
- Statistical techniques - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1260082 |
| April 19, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1012619 |
| March 3, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 962212 |
| September 13, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 800241 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kaneka Corporation
FEI Number
3002808904
Address
5 Chome 1-1, Torikainishi, Settsu, Japan
Country
Japan
ID: 3f38f4de-3d78-415b-91d6-945a7bee153f