FDA Inspection
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya OfficeFUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office, with an inspection on January 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 30, 2014
- Product Type
- Devices
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ID · 2da6b2b4-c5a9-4ada-a7c6-0fa605020adf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868220
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.184DHR content
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Other FDA inspections of FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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