FDA Inspection
FujiFilm Healthcare Americas CorporationFujiFilm Healthcare Americas Corporation – FDA Inspection, Feb 1, 2010
Record Details
This FDA Inspection record concerns FujiFilm Healthcare Americas Corporation, with an inspection on February 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 1, 2010
- Product Type
- Devices
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ID · dfa20eeb-6f60-4891-9115-0f8229576aac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640242
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of FujiFilm Healthcare Americas Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 8, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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