FDA Inspection
Sysmex RA Co., LTDSysmex RA Co., LTD – FDA Inspection, Apr 20, 2017
Record Details
This FDA Inspection record concerns Sysmex RA Co., LTD, with an inspection on April 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ac88ab4e-0f05-4463-81ee-92d6c4a1b6a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015622
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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