Company
JapanSysmex RA Co., LTD, Shiojiri, Japan – FDA Inspections
Inspection records and compliance data for Sysmex RA Co., LTD in Shiojiri. 1 FDA inspection on record, 1 Form 483, last inspected April 20, 2017.
Company Profile
This profile covers Sysmex RA Co., LTD based in Shiojiri, Japan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 20, 2017.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 20, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1015622 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sysmex RA Co., LTD
FEI Number
3010188766
Address
1850-3, Oazahirookano-Mura, Shiojiri, Japan
Country
Japan
ID: a1bc5101-f1c5-4744-acdb-8e5513655cf5