FDA Inspection
FUJIFILM Healthcare Americas CorporationFUJIFILM Healthcare Americas Corporation – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns FUJIFILM Healthcare Americas Corporation, with an inspection on March 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dd580004-117e-4a2d-9e7a-5b39653ec7f3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1046796
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1002.20(a)Failure to report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of FUJIFILM Healthcare Americas Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 31, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FUJIFILM Healthcare Americas Corporation
- FDA Inspection 1095860 - 2019-06-21
- FDA Inspection 994698 - 2016-11-10
- FDA Inspection 991423 - 2016-10-31
- FDA Inspection 919044 - 2015-02-19
- FDA Inspection 810738 - 2012-12-12
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