Company
United StatesMizuho OSI, Union City, CA – FDA Inspections
Inspection records and compliance data for Mizuho OSI in Union City, California. 4 FDA inspections on record, last inspected February 25, 2016.
Company Profile
This profile covers Mizuho OSI based in Union City, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 2, 2010. Last inspected February 25, 2016.
Most cited issue areas
- Evaluation, timeliness, identification1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 25, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 968511 |
| September 25, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 850919 |
| September 11, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 798286 |
| June 2, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 661263 |
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
Mizuho OSI
FEI Number
2921578
Address
30031 Ahern Ave, Union City, California 94587, United States
Country
United States
ID: adece774-aa31-473f-9e7f-3db559ad73e2