Company
JapanRiken Keiki Co., Ltd., Tokyo, Japan – FDA Inspections
Inspection records and compliance data for Riken Keiki Co., Ltd. in Tokyo. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 30, 2025.
Company Profile
This profile covers Riken Keiki Co., Ltd. based in Tokyo, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 9, 2015. Last inspected January 30, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Lack of Written MDR Procedures2 inspections
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 30, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1259495 |
| December 9, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 955935 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Riken Keiki Co., Ltd.
FEI Number
3002808005
Address
2-7-6 Azusawa Itabashi-ku, Tokyo, Japan
Country
Japan
ID: 6cb32b29-e37a-42e2-a8fb-ed171c711836