FDA Inspection
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya OfficeFUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office – FDA Inspection, Sep 12, 2019
Record Details
This FDA Inspection record concerns FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office, with an inspection on September 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 12, 2019
- Product Type
- Devices
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ID · f2cc58de-79bd-4ee0-9799-67535c42c189
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1115202
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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