Company
JapanSYSMEX CORPORATION I-SQUARE, Kakogawa, Japan – FDA Inspections
Inspection records and compliance data for SYSMEX CORPORATION I-SQUARE in Kakogawa. 1 FDA inspection on record, last inspected September 16, 2016.
Company Profile
This profile covers SYSMEX CORPORATION I-SQUARE based in Kakogawa, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 16, 2016.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 990227 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SYSMEX CORPORATION I-SQUARE
FEI Number
3010960914
Address
Mizuashi 262-11, I-SQUARE, Noguchi-Cho, Kakogawa, Japan
Country
Japan
ID: d792121c-b6fc-4b05-b8bf-cd84b4dd965f