Company
JapanKaken Pharmaceutical Co., Ltd., Fujieda, Japan – FDA Inspections
Inspection records and compliance data for Kaken Pharmaceutical Co., Ltd. in Fujieda. 4 FDA inspections on record, 1 Form 483, last inspected September 01, 2023.
Company Profile
This profile covers Kaken Pharmaceutical Co., Ltd. based in Fujieda, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2012. Last inspected September 1, 2023.
Most cited issue areas
- Backup file not maintained1 inspection
- Identification of Equipment and Lines1 inspection
- input/output verification1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1219421 |
| June 22, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1056547 |
| March 28, 2014 | VAI | Human Drugs · Drug Quality Assurance | 873743 |
| November 14, 2012 | NAI | Human Drugs · Drug Quality Assurance | 813922 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Kaken Pharmaceutical Co., Ltd.
FEI Number
3002807376
Address
Kakenseiyaku (Kabu) Shizuokakojo, 301; Gensuke, Fujieda, Japan
Country
Japan
ID: 047de00d-0f41-4808-8bcb-58970bebd083