FDA Inspection
Fujifilm Medical Systems USA, Inc.Fujifilm Medical Systems USA, Inc. – FDA Inspection, Nov 22, 2013
Record Details
This FDA Inspection record concerns Fujifilm Medical Systems USA, Inc., with an inspection on November 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 22, 2013
- Product Type
- Devices
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ID · 9055fb4b-6ed6-4324-9af3-f0a3f155b4de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856397
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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