FDA Inspection
Sysmex Reagents America, Inc.Sysmex Reagents America, Inc. – FDA Inspection, Jun 7, 2016
Record Details
This FDA Inspection record concerns Sysmex Reagents America, Inc., with an inspection on June 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 7, 2016
- Product Type
- Devices
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ID · f2c1b869-712f-4cf2-b334-e1ddc2c61f4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984894
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Sysmex Reagents America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sysmex Reagents America, Inc.
- FDA Inspection 773199 - 2012-02-06
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