Company
JapanMani, Inc. - Kiyohara Facility, Utsunomiya, Japan – FDA Inspections
Inspection records and compliance data for Mani, Inc. - Kiyohara Facility in Utsunomiya. 3 FDA inspections on record, last inspected July 11, 2018.
Company Profile
This profile covers Mani, Inc. - Kiyohara Facility based in Utsunomiya, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 7, 2010. Last inspected July 11, 2018.
Most cited issue areas
- Complaints2 inspections
- Documentation2 inspections
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1060864 |
| May 23, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 837793 |
| October 7, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 695735 |
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
Mani, Inc. - Kiyohara Facility
FEI Number
3002692886
Address
Park 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi, Utsunomiya, Japan
Country
Japan
ID: 4d67ad39-155e-479c-b7ca-05ee3901203e