Company
JapanARKRAY Factory, Inc., Koka, Japan – FDA Inspections
Inspection records and compliance data for ARKRAY Factory, Inc. in Koka, -. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected October 08, 2014.
Company Profile
This profile covers ARKRAY Factory, Inc. based in Koka, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected August 4, 2011. Last inspected October 8, 2014.
Most cited issue areas
- Calibration procedures - content1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 8, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 902902 |
| August 4, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 743581 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ARKRAY Factory, Inc.
FEI Number
3003422726
Address
Koka, - -, Japan
Country
Japan
ID: 13dea73e-0632-4d5a-810e-78ce8616c5e2