FDA Inspection
Sysmex CorporationSysmex Corporation – FDA Inspection, Jan 17, 2013
Record Details
This FDA Inspection record concerns Sysmex Corporation, with an inspection on January 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sysmex Corporation
- Inspection Date
- January 17, 2013
- Product Type
- Devices
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ID · e7eb7a6a-cdb3-47d4-885d-ae88e4d89607
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817094
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
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