Company
JapanKOWA CO. LTD. CHOFU, Chofu, Japan – FDA Inspections
Inspection records and compliance data for KOWA CO. LTD. CHOFU in Chofu, Tokyo. 2 FDA inspections on record, 1 Form 483, last inspected July 18, 2024.
Company Profile
This profile covers KOWA CO. LTD. CHOFU based in Chofu, Tokyo, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 5, 2018. Last inspected July 18, 2024.
Most cited issue areas
- Design validation acceptance criteria1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1243999 |
| July 5, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1058995 |
FDA documents
Form 483s (2)
People (2)
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Company Information
Name
KOWA CO. LTD. CHOFU
FEI Number
3011223751
Address
3 Chome 3-1 Chofugaoka, Chofu, Tokyo 182-0021, Japan
Country
Japan
ID: b31d7629-c044-4b1a-b856-7bbeae463dc7