FDA Inspection
FUJIFILM Healthcare Americas CorporationFUJIFILM Healthcare Americas Corporation – FDA Inspection, Jun 21, 2019
Record Details
This FDA Inspection record concerns FUJIFILM Healthcare Americas Corporation, with an inspection on June 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 482ddb56-56bc-412a-9d42-3e6a54921139
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095860
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of FUJIFILM Healthcare Americas Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 1046796 - 2018-03-29
- 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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