Company
JapanARKRAY, Inc., Kyoto, Japan – FDA Inspections
Inspection records and compliance data for ARKRAY, Inc. in Kyoto. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected October 10, 2014.
Company Profile
This profile covers ARKRAY, Inc. based in Kyoto, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected February 9, 2009. Last inspected October 10, 2014.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 10, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 902883 |
| August 2, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 742939 |
| February 9, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 568755 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ARKRAY, Inc.
FEI Number
3002807423
Address
Kamigyo 59, Gansuin-Cho; Kamigyo, Kyoto, Japan
Country
Japan
ID: a55c19f1-eab4-4b29-b39f-b10547799bda