Company
JapanFUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office, Hitachiomiya, Japan – FDA Inspections
Inspection records and compliance data for FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office in Hitachiomiya. 3 FDA inspections on record (2 OAI), 1 Form 483, last inspected September 12, 2019.
Company Profile
This profile covers FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office based in Hitachiomiya, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 30, 2014. Last inspected September 12, 2019.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2019 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1115202 |
| April 20, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 927844 |
| January 30, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868220 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office
FEI Number
3010516924
Address
4112 Tono, Hitachiomiya, Japan
Country
Japan
ID: 0f7cf182-a83f-4022-abc6-3f752ff958ef