FDA Inspection
Fujifilm CorporationFujifilm Corporation – FDA Inspection, Sep 22, 2023
Record Details
This FDA Inspection record concerns Fujifilm Corporation, with an inspection on September 22, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7a18e04-1b71-438f-8c2b-3e452a37951b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219107
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.52(a)(1)Patient Name or Other Identifier
- 21 CFR 803.52(e)(1)Contact Office Name and Address
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.52(a)(1)Patient Name or Other Identifier
- 21 CFR 803.52(e)(1)Contact Office Name and Address
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fujifilm Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 8, 2016 | Not classified | Office of Inspections and Investigations | |
| April 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fujifilm Corporation
- FDA Inspection 1115949 - 2019-09-30
- FDA Inspection 1061550 - 2018-07-13
- FDA Inspection 995868 - 2016-12-08
- FDA Inspection 837192 - 2013-04-25
- FDA Inspection 590137 - 2009-06-11
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