Company
JapanTokyo Boeki Medisys, Inc., Hino, Japan – FDA Inspections
Inspection records and compliance data for Tokyo Boeki Medisys, Inc. in Hino. 2 FDA inspections on record, 1 Form 483, last inspected March 24, 2017.
Company Profile
This profile covers Tokyo Boeki Medisys, Inc. based in Hino, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 27, 2014. Last inspected March 24, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design verification - documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009378 |
| February 27, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 868114 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Tokyo Boeki Medisys, Inc.
FEI Number
3004378326
Address
1 Chome 14-21, Higashitoyoda, Hino, Japan
Country
Japan
ID: 6b1c2d80-9c70-4415-95a8-db3912d9eb10